Shalti Orthopedic Industries (P} ite New Delhi, india Risk Management Record 1.0 Risk Analysis Risk Analysis has been conducted as per defined procedure OP-7 & ISO 14971 (2001) 1.1. Data related to Non Sterile Orthopedic Screws , Orthopedic Nails, Orthopedic Plates, Orthopedic Pins & Wires , Spinal Implants, Orthopedic Prosthesis, Orthopedic instruments like Cutting Instruments , Bone holding instruments, Retractors / Levers, Measuring Instruments, Driving / Insertion Instruments Bending Instruments, Guides and Aiming Instruments, Tightening Instruments and External Fixators like Tubular, Ring, Distraction / ‘Compression Instruments. SN ‘Question ‘Answer i. | Whats the intended use /intended purpose and how | Used for general surgery conducted | _| isthe medical device to be used. on patients. i, 1s the medical device infended to confact the | Yes. It comes in contact with patient / other person ? patient's body and also. with surgeon's hands ii, | What material 7 components are incorporated in__| High Carbon Steel, Stainless Steel medical device or used with medical device ? Medical grade Plastic in case of | scalpel handles. |v. [is the energy delivered to ond / subtracted from | No. the patient. v.__| Are substances delivered fo and / extracted from _| No. the patient? vi, | Are biological materials processed by the medical _| No. device for subsequent reuse. 1s the medical device supplied sterile /intended to | No. be sterilized by the user or other microbiological | It needs to be sterilized by the user controls applicable # prior fo use in surgery. |s the medical device intended to be routinely | No. cleaned and disinfected by the user ? ix [Js the medical device intended to modify the _ | No. | patient environment ? x | Are measurements taken? Ne. xi, _| Is the medical device interpretative? No. | xi, | 15 the medical device intended of use in | No. conjunction with medicines . other medical | E technology? xi, [Are there unwanted outpuls of energy or | No. substances @ xiv. [Is the medical device susceptible fo environmental _| Yes — Rusting of medical devices may influences ? take place. | xv. | Does the medical device affect the environment? _| No. | [wi [Are there essenfial consumables associated with | Nil the medical device @ xvit_[Is maintenance and / calibration necessary xvi. | Does the medical device contain software? Issue :01 Rev. 01 Dt, : 2-1-2006Shobti Orthopedic Industries (P} Uct New Deihi, indi. ical device have a shelf life @ Does the m temperature in a dry place. Are there any delayed / long lime use effects @ 5 Yrs if stored under = No. To what mechanical forces will the medical device be subjected? Mechanical force applied by Surgeon for cutting / invasion. What determines the life time of the medical | device? Rusting of materiol & Validity of sterlization. I5 the medical device intended for single use? Yes. Is safe decommissioning / disposal of the medical | device necessary? | Any specialized training required to the user @. Yes. Since affer use it may aries microbial load which could cause infection on contacting, the sate disposal is essential as bio waste. No. 1 Is the successful application of medical device critically depend on human interface? Yes Does the installation / use of medical device require special training? Yes. User must be qualified surgeon. Will _new manufacturing proceses need fo | No established / introduces. | vai. | IS the successful application of the medical device | Yes. critically dependent on human factor such as user | interface. xa, | Does the medical device has connecting pars 7 | No. accessories? eA yall | Does the medical device have a conirolinierface® | No. xxii. | Does the medical device display information? No. ] >on | 1s the medical device controlled by a menu? No. voaiv.[ Is the medical device intended to be mobile / | No. Portable, Issue 01 Rev. 01 Dt. : 2-1-2006 Reviewed & Approved Puss £0