Medical Devices Risk Management Report

（Metal Intramedullary Nails）

File No.：HS/CE.JS-05

Edition：B/0

Preparers: Quanhua Zhang Date：2013.02.17

Checkers: Date：

Approved by: Date：

Changzhou Waston Medical Appliance Co.,Ltd

9 Xihu Road, Wujin Hi-tech Industry Zone, Changzhou，213164
 Contents

Chapter 1 Abstract

1.1 Product Introduction

1.2 The Scope of Risk Management

1.3 The Risk Management Staff & Division of Responsibilities

1.4 Basis for Preparing The Risk Management Report

Chapter 2 Risk Assessment Guidelines

2.1 Hazard Severity Level

2.2 Hazard Occurrence Probability Level

2.3 Risk evaluation criterion

Chapter 3 Intended Use / Intended Purpose & Judgment of Security-related characteristics

Chapter 4 Decision of Known or Foreseeable Hazards & Hazard Analysis

4.1 Preliminary Hazard Analysis（PHA）

4.2 Use DFEMA(Design Failure Mode and Effect Analysis ) for risk analysis about product safety -related

failure mode according to risk management process during the design and development stage.

4.3 Use PFEMA(Process Failure Mode and Effect Analysis ) for risk analysis about product safety-related

failure mode according to risk management process during the production stage.

Chapter 5 Risk Estimation, Risk Evaluation, Risk Control & Risk Control Measures verification

5.1 Risk Estimation & Risk Evaluation

5.2 Risk Control & Risk Control Measures verification

Chapter 6 Residual Risk Evaluation

Chapter 7 Post-production Information

Chapter 8 Conclusion
 Chapter 1 Abstract

1.1 Product Introduction

1.1.1 Product description
Metallic intramedullary nails’ shapes and sizes were established based on length, diameter of human limb
bones and operation approach methods. The products mainly consists of the main nail, lag screws, locking
screws and sealing cap etc and other components; all these are optional accessories except for main screw and
their number will be different according to the different clinical symptoms. According to different use of
location and operation approach methods, intramedullary nails can be divided into tib ial intramedullary nail,
femoral intramedullary nail, reconstruction intramedullary nail, GAMMA intramedullary nail, Universal
retrograde intramedullary nail and humeral intramedullary nail. The metal intramedullary nails we
manufacture are made from stainless steel, which is compliant with ISO5832 -3: 1996 (E) 'Surgical Implants.
Metallic materials. Part 1: Forged Stainless Steel. It is provided non-sterilized.
1.1.2 Classification of Product & Rule

IIb, MDD 93/42/EEC, Appendix IX, Rule 8。

1.1.3 GMDN Code

56643、56645、56644
1.1.4 Application
The products are used for the internal fixation of diaphysis or epiphysis fracture in orthopedic surgery
(including tibial, femoral and humeral)
1.2 Scope of Risk Management
1、Product realization（including design and development, purchase, manufacture and package etc.）
2、Delivery process（including transportation etc.）
3、After delivery
4、Deal with Scraped（failure）products
1.3 Risk management staff & division of responsibility
Table 2
Position
Serial
Risk manger within the Division of responsibility Remark
No.
group
1 Renming Hu Leader Approval of the risk management report
Team Mange the risk of product delivery process and the
2 Xiaochun Hu
member stage after delivery
Team Manage the risk of product design and development,
3 Jiaping Yang
member manufacturing stage and packing stage
Team
4 Jin Zhou Manage the risk of material purchasing stage
member
Team
5 Huaquan Zhang Prepare the risk management report
member
Team
6 Hua zhou Manage the risk of monitoring and measuring stage
member
1.4 Basis for Preparing The Risk Management Report
1.4.1 Relative Standard
⑴Medical Device Application of risk management to medical devices（YY/T 0316：2008）
⑵Surgical implants Basic Rules（YY/T0340）
⑶Osteosynthesis Non-active surgical implants - General requirements（YY/T0341-2009）
⑷Forged stainless steel for surgical implants（GB/T13810-2007）
⑸Metal bone screws》Product register standard and others
1.4.2 Relative documents
1、Product standardize and development files
(1) Design project plan descriptions
(2) Product instruction Manual
(3) Design Verification Report
(4) Product drawings
⑸ Process documents
⑹ Processes Standard operation procedure
⑺ Product packaging standardize
⑻ Process capability Verification report
⑼ Product performance self-test report
⑽ Product Type inspection report
⑾ Clinical trial report
⑿ Inspection procedures
2、Other sources of information
⑴Articles from the professional literature and other information
⑵Medical Device Application of risk management to medical devices Publicizing tutorial

Chapter 2 Risk Assessment Guidelines

2.1 Hazard Severity Grading
Table 3
Severity Level possible
description
Negligible Inconvenience or temporary discomfort
Minor Results in temporary injury or impairment not
requiringprofessional medical intervention
Serious Results in injury or impairment requiring professional medical
intervention
Critical Results in permanent impairment or life-threatening injuries
Catastrophic Results in patient death
2.2 Hazard Occurrence Probability Levels
Table 4
Probability Level Range of probability
Frequent ≥10 3
 Probale ＜10 3 &≥10 4
Occasional ＜10 4 &≥10 5
Remote ＜10 5 &≥10 6
Improbable ＜10 6
2.3 Risk evaluation criterion
Table 5
Severity （S）
（P）
Probability 1 2 3 4 5
Negligible Minor Serious Critical Catastrophic
Frequent
5 ACC 10 ALARP 15 NACC 20 NACC 25 NACC
（5）
Probale（4） 4 ACC 8 ALARP 12 NACC 16 NACC 20 NACC
Occasiona（
l 3） 3 ACC 6 ACC 9 ALARP 12 NACC 15 NACC
Remote
2 ACC 4 ACC 6 ACC 8 ALARP 10 ALARP
（2）
Improbable
1 ACC 2 ACC 3 ACC 4 ACC 5 ACC
（1）
Note：①ACC—widely acceptable area； NACC—Area unacceptable； ALARP—reasonable lower
area.②1～6-Reception area；7～11-reasonable reduction zone；12～25-non-receiving area。
③ risk level = severity（S）×probability（P）。
Chapter 3 Intended Use / Intended Purpose & Judgment of Saftey-related characteristics
Table 6
No. Factors Features
Used for the internal fixation of diaphysis
What is the intended use and how is the medical or epiphysis fracture in orthopedic surgery
1
device to be used?？ (including tibial, femoral and humeral) in
accordance with product instruction.
Belong to orthopedic internal fixing
2 Is the medical device intended to be implanted? material.To be implanted into patient’s
body by clinician for single use.
Implated into the place of patient’s body
Is the medical device intended to be in contact with
3 where need internal fixation.To be get out
the patient or other persons?
by doctor after healing.
The implanted material it is stainless steel
What materials or components are utilized in the
for surgical implants in accordance with
4 medical device or are used with, or
GB/T13810-2007
are in contact with, the medical device?
requirements.
Is energy delivered to or extracted from the
5 No.
patient?
Are substances delivered to or extracted from the The products will be implanted into the
6
patient? body to connect the fracture ends.
Are biological materials processed by the medical
7 device for subsequent re-use, No.
transfusion or transplantation?
 Is the medical device supplied sterile or intended to
Product is delivered unsterilized should be
8 be sterilized by the user, or are other
sterilized before use.Only for single use.
microbiological controls applicable?
Is the medical device intended to be routinely
9 Yes, according to product instruction.
cleaned and disinfected by the user?
Is the medical device intended to modify the
10 No
patient environment?
11 Are measurements taken? No.
12 Is the medical device interpretative? No.
Is the medical device intended for use in
13 conjunction with other medical devices, Need to be used during operation.
medicines or other medical technologies?
Are there unwanted outputs of energy or
14 No.
substances?
Is the medical device susceptible to environmental
15 No.
influences?
Does the medical device influence the
16 No.
environment?
Are there essential consumables or accessories
17 No.
associated with the medical device?
18 Is maintenance or calibration necessary? No.
19 Does the medical device contain software? No.
Does the medical device have a restricted
20 No.
shelf-life?
No, It should be removed after fracture
21 Are there any delayed or long-term use effects?
healing.
To what mechanical forces will the medical device Mechanical force by operator during the
22
be subjected? implanting process.
The operation of doctor, the quality of
What determines the lifetime of the medical
23 products and whether patients follow the
device?
doctor's advice.
Just for single use. It should be destroyed
24 Is the medical device intended for single use?
by doctor after removal.
Is safe decommissioning or disposal of the medical It should be removed from the body
25
device necessary? through operation after fracture healing.
Yes, only the doctor have the qualification
Does installation or use of the medical device
26 above attending physician can operate this
require special training or special skills?
product.
27 How will information for safe use be provided? See product instruction.
Will new manufacturing processes need to be
28 No.
established or introduced?
Can the user interface design features contribute to
29 No.
use error?
 Is successful application of the medical device
critically dependent on human factors No.
such as the user interface?
Is the medical device used in an environment
No.
where distractions can cause use error?
Does the medical device have connecting parts or
Yes, there are screws holes on the plates.
accessories?
Does the medical device have a control interface? NO.

Does the medical device display information? No.

Is the medical device controlled by a menu? No.

Will the medical device be used by persons with
It shall be used by professional clinician.
special needs?
Can the user interface be used to initiate user
No.
actions?
30 Does the medical device use an alarm system? No.
In what way(s) might the medical device be
31 No.
deliberately misused?
Does the medical device hold data critical to
32 No.
patient care?
Is the medical device intended to be mobile or
33 No.
portable?
Does the use of the medical device depend on
34 No.
essential performance?

Chapter 4 Decision of Known or Foreseeable Hazards & Hazard Analysis

4.1 Preliminary Hazard Analysis（PHA）

Table 7
Hazard
No. Possible hazards Forming factors
Classification
Energy /
A1 No
hazards
Although the intramedullary nailshas
steam sterilization before using,, the
insufficient control for production
process (like ending cleaning and
primary packing) may still cause high
microbial amount, after sterilization, the
Biological dead microbial and their products
B1 Biological pollution maycause wound infections (such as
hazards
skin irritation, skin sensitization, and so
on) and difficult to heal. Intramedullary
nails are intended for single use, if the
clinician don’t follow the warning marks
to repeat use may cause cross infection
and artificial medical malpractice.
 The detergent is not rinsed cleanly
B2 Chemical pollution during the production process.
B3 Biocompatibility Non-conforming raw material
Storage departure from a predetermined
Environment Not in accordance with the provisions of
C1 environmental condition, spots on the
al hazards surface of product. storage (such as wet)
Equipment contamination caused by Non-conforming package and
D1
damaged package inappropriate operation.
Incorrect lableing or misjudgment of the
D2 An error or inappropriate labelling
lableing
Review, verification, and validation is
D3 Inadequate warning of side effects
not enough of instruction.
Review, verification, and validation is
D4 Inadequate warning of contraindication
not enough of instruction
Medical D5 Inadequate Operate Not follow the operating instruction
device Review, verification, and validation is
use-related D6 Inadequate Operating instructions
not enough of instruction
hazards Used by unskilled or untrained Doctor's clinical experience is not
D7
personnel sufficient
Preoperative planning is not meticulous
D8 Reasonable and predictable misuse
enough
Patients not according to a doctor’s
D9 Implant loosening, bent or broken advise to have early weight-bearing, and
not regular review.
Do not sterilize the medical device
D10 Equipment damaged.
according with specified parameters
Harm caused
by functional
failure and E1 Scratch on the surface of product The scratch or collision during transport
poor
maintenance
The chemical composition and
F1 microstructure of the material used in Non-comforming raw material
Raw material products non-conformate
F2 Surface discontinuity defects Inspection do not follow standard
imperfections of design Review, verification, and validation is
G1
not enough
Design
Technology or processes are not Review, verification, and validation is
G2
reasonabl not enough
Scratch due to not operate according to
The surface roughness do not meet the
H1 the craft file or during the component
drawing requirements transport.
Microstructural changes during Coolant supporting is not timely during
H2
machining process the process.
Production Coolant pipe blockage or damaged
H3 Untimely coolant
process cooling pump is not timely repaired
H4 Parts cleaning uncleanly Operation not follow the instructions
The size of the matching parts is
H5 Measuring not follow requirements.
unreasonable
the polishing process failed to eliminate
H6 Parts with sharp edges or sharp corners
sharp edges or sharp corners
4.2 Use DFEMA(Design Failure Mode and Effect Analysis ) for risk analysis about product safety -
related failure mode according to risk management process during the design and development stage.
Table 8
Potential failure Reason and mechanism of
Program Potential failure mode Hazard No.
effect potential failure
Improper Material
Lead to patient
Unqualified compatibility suppliers choose,
allergies, severe B3
of the raw materials. non-implant materials are
cases even death. used
The clinical The non-conformity raw
Unqualified chemical
Raw implants fracture, material, Not inspection
composition and
patient disability according to the standard F1
material microstructure of raw
and even death in requirements
material.
severe cases.
The non-conformity raw
Product scrap,
Discontinuity defects on material, Not inspection
internal plant F2
the surface of material. according to the standard
fracture. requirements
Defective structure, Internal fixation
Unreasonable structure
performa internal fixation is not loosening, need for G1
design
reliable,easy to loose. secondary operation.
nce
Surface with sharp Unreasonable request on
structure Injury to the patient
edges, burrs and dents, or medical personnel
the surface quality of G1
surface roughness. products.
The cleaning stage is not
Cause wound confirmed and the
Craft Splodge on the surface. G2
infection technical process is in
confusion.
4.3 Use PFEMA(Process Failure Mode and Effect Analysis ) for risk analysis about product
safety-related failure mode according to risk management process during the production stage.
Table 9
Potential failure Reason and mechanism of
Program Potential failure mode Hazard No.
effect potential failure
The mechanical
properties of the Coolant pipe blockage
Changes of the
material change, or damaged cooling
microstructure in the H2
and the material pump is not timely
machining process
is prone to repaired
Mechanical breakage.
processing Cooperation is not
The fitting parts’ size is Do not be monitored and
smooth or not H5
not good. measured on request.
interchangeable.
Parts with sharp Post polishing process
Injury to the patient
edges or sharp failed to eliminate sharp H6
or medical personnel
corners edges or sharp corners.
Surface with sharp Scratch due to not
Surface edges, burrs and Have damage to operate according to H1
treatment dents, surface medical staff the craft file or during
roughness. the component
 transport.

Labelling mistake or u
Labelling Misuse
Laser marking or label D2
nsuitability
making error.

Parts Operation not according to

Spot on the product Cause wound
the cleaning standerd H4
cleaning surface. infection
operation procedure
Do not operate according
Package easy to be Cause wound
Package to packing and sealing D1
broken infection
standerd operation

Chapter 5 Risk Estimation, Risk Evaluation, Risk Control & Risk Control Measures verification

5.1 Risk Estimation & Risk Evaluation

Table 10
Hazard Severit Probab Risk
Hazar Risk
classificatio Possible hazard y ility acceptabil
d No. level
n degree degree ity
Energetic No.
A1 / / / /
hazard
B1 Biological pollution 4 1 4 ACC
Biological
B2 Chemical pollution 3 2 6 ACC
hazard
B3 Biocompatibility 5 1 5 ACC
Storage departure from a predetermined
Environmen
C1 environmental condition, spots on the 3 1 4 ACC
tal hazard
surface of product.
Equipment contamination caused by
D1 3 1 3 ACC
damaged package
D2 An error or inappropriate labelling 4 1 4 ACC
D3 Inadequate warning of side effects 4 1 4 ACC
D4 Inadequate warning of contraindication 4 1 4 ACC
Medical
D5 Inappropriate use 3 3 9 ALARP
device
D6 Inappropriate instruction 3 1 3 ACC
use-related
Used by unskilled or untrained
hazard D7 4 2 8 ALARP
personnel
D8 Reasonable and predictable misuse 4 1 4 ACC
D9 Implant loosening, bent or broken 4 2 8 ALARP
Do not sterilize the medical device
D10 4 1 2 ACC
according with specified parameters
Harm
caused by
functional
failure and E1 Scratch on the surface of product 3 2 6 ACC
poor
maintenanc
e
The chemical composition and
Raw F1 microstructure of the material used in 4 1 4 ACC
 material products non-conformated

F2 Surface discontinuity defects 4 2 8 ALARP

G1 imperfections of design 3 1 3 ACC
Design The rationality of the craft and
G2 technological process 3 1 3 ACC
The surface roughness do not meet the
H1 3 3 9 ALARP
drawing requirements
Microstructural changes during
H2 machining process 3 1 3 ACC
Production
H3 Untimely coolant 4 2 8 ALARP
process
H4 Parts cleaning uncleanly 3 2 6 ACC
The size of the matching parts is
H5 unreasonable 4 1 4 ACC
H6 Parts with sharp edges or sharp corners 3 3 9 ALARP

5.2 Risk Control & Risk Control Measures verification

Risk control measures and verification for unacceptable and reasonable reducible risk according the

judgment from last step are recorded as follows：

From the evaluations above, we can know the risk acceptable grade of the product. The risk in the widely

acceptable area of B1～B3、C1、D1、D1～D4、D6 、D8、D10、E1、F1、G1、G2、H2、H4 and H5do not

need any more control measures. The risk in reasonable reducible area and unacceptable area have to make

more measures to control.

Table 11
Need risk Severity Probability
Risk degree Verification
control Relevant measure to reduce risk degree degree
result
No. BEF AFT BEF AFT BEF AFT
D5 Strengthen training 5 5 3 1 15 5 ACC
Improve management and
D7 5 5 2 1 10 5 ACC
training
Tell patient the importance and
necessity to follow doctor’s
D9 4 4 2 1 8 4 ACC
advice and have regular
follow-up review.
To strengthen the quality control
F2 of purchasing and incoming 4 4 2 1 8 4 ACC
inspection
Strengthen the training, quality
H1 inspection, and strict 3 3 3 1 9 3 ACC
discipline.
Regularly check the coolant
forwarding pipe. In case of poor
transportation ，timely clear. In
H3 4 4 2 1 8 4 ACC
case of damage to the cooling
pumps, should timely stop use
and be disable before repair.
 Strengthen the training, quality
H6 3 3 3 1 9 3 ACC
inspection, and strict discipline.

Chapter 6 Remainder Risk Assessment

After taking some measures to reduce the risk,risk hazard of D5、D7、D9、F2、H1、H3 and H6 etc has
been reduced to widely acceptable degree and there is no new risk. So, for the remainder risk from Table 10
（risk in widely acceptable area of B1～B3、C1、D1～D4、D6、D8、D10、E1、F1、G1、G2、H2、
H4 and H5）and Table 11, the benefits outweigh the risks and don’t need to reduce the risk.

Chapter 7 Post-production Information

Since the metal intramedullary nails were approved for list ing, we organized the production in strict
accordance with the requirements of product technology file and strictly controlled product quality. At the
same time, we timely tracked the quality of the products after the listing with re-analysis, evaluation and
control of the risk after production following the requirements of YY0316 -2008 Medical Devices Risk
Management for Application. In addition, with the requirements of the Medical Device Manufacturing
Practices Implantable Medical Device Implementing Rules (Trial), the final cleaning of the products and
primary packaging were both production in 100,000 clean controlled region to reduce particulate pollution, oil
pollution and the initial pollution bacteria from the beginning. This will help to reduce the risk for patients due
to the substandard productive cleanliness.We will strictly control and monitor the situation of the clean area by
YY0033.Since the products was listed, the quality is stable without adverse event and well received by
customers.
Chapter 8 Conclusion
In summary：Before taking control measures, Unacceptable risk No.:0
Reasonable reducible risk No.:7
Acceptable risk No.：18
After taking control measures, Unacceptable risk No.:0
Reasonable reducible risk No.:0
Acceptable risk No.：25

Through the analysis, evaluation and taking necessary risk control measures, all the risk have been reduced to
the widely acceptable level; the remainder risk is acceptable with benefits outweigh the hazard. To timely
follow the post-production information (listed products),the quality is stable without adverse event and well
received by customers since listing. So the risk management team believe the products are safe.