Unima Blue

7.2 mm cannulated compression screw

INDICATIONS ture stabilization.

Unima Blue
Cannulated diameter : 1.6mm

The Unima Blue 7.2 mm cannulated compression screw is indicated for fixation of osteotomies or for fracFixation of bone fragments, Calcaneal osteotomy, Triple arthrodesis, Calcaeneocuboid, talocalcaneal, talonavicular, talotibial joints arthrodesis.

Length of proximal head : 10 mm Head diameter : 8.7 mm Traceable lot number

Shank diameter : 4.2 mm Distal diameter : 7.2 mm Distal threaded length : 18 mm or 36 mm for 90 up to 120 mm screws

DESCRIPTION 7.2mm cannulated compression screw made from Titanium alloy. Completely countersunk screw. Large range of sizes : 40 to 120 mm ( in 5mm increment ) 2 distral thread lengths for 90 up to 120 mm screws : 18mm for calcaneotalar arthrodesis, 36 mm for talocalcaneal arthrodesis.

1.5 mm k-wire drilling and screwing. Self-tapping and self-drilling One drilling guide for triple arthrodesis Titanium alloy ( T A6V ELI in compliance with ISO 5832-3 standard )

Unima Blue
Drilling guide for triple arthrodesis
Unima driling guide is reversible to adapt both talocalcaneal or calcaneotalar arthrodeses.

Set up the Unima guide.

This Unima guide features new assets :

A reinforced corner to provide a better stabilisation.

4 k-wires can be introduced in the lowest extremity of the guide. The guide is thus definitively fixed.

Unima Blue
Drilling guide for triple arthrodesis
Prior to k-wire insertion, the K-wire guide with the smallest hole should be selected.

The K-wire guide is then introduced through the Unima guide.

Stabilisation of the lowest part of the guide. Only pins should be introduced into the bone (talus for calcaneotalar arthrodesis and calcaneus for talocalcaneal arthrodesis).

The 1.5mm k-wire is inserted through the talus and calcaneus bones.

Unima Blue
Drilling guide for triple arthrodesis
Removal of the k-wire guide while the k-wire is left in place. The appropriate drilling guide with the biggest hole should be selected and inserted through the Unima guide.

Non cannulated 4.2mm drill

Cannulated 4.2 mm drill

AP07.125

AP07.124

Measurement of screw length. The length of the screw is indicated both on the drill AND on the Unima guide. A double reading is available. Care should be taken to remove 5 mm from the indicated length to prevent damages to the second cortical.

Unima Blue
Drilling guide for triple arthrodesis
Prior to the screw insertion, it might be necessary to prepare a tapped hole in young patients or in presence of hard bone. Once the drilling guide has been removed, the cannulated taped tool can be inserted.

Use the one-stage drill for preparing the screw head anchorage hole. This procedure is only necessary when the screw is introduced from calcaneus to talus. There is no need to prepare a screw head anchorage hole into the talus bone which is naturally soft.

AP07.126

Once the tapped hole has been prepared and drilling for distal and proximal parts of the screw, proper insertion of the screw may be then performed. The screwdriver is AO compatible with power drill,or it is as well possible to screw with T-handle cannulated screwdriver.

AP07.117 AP07.022

Unima Blue
Drilling guide for triple arthrodesis
Screwing.

Compression appears while the screw is being threaded. The screw head has to be embedded in order to avoid any conflict with soft tissues.

Unima Blue
INSTRUCTIONS FOR USE LEAFLET

FOOT IMPLANTS/INTERNAL FIXATION IMPLANTS

STERILE DISPOSABLE PRODUCTS
According to decree no. 95-292 of 16 March 1995 (directive 93/42/CEE) relating to medical devices, this product must be handled and/or implanted by trained QUALIFIED PEOPLE who have READ AND UNDERSTOOD this INSTRUCTIONS FOR USE LEAFLET.

1 - Description of the medical devices:

The implants, which are delivered sterile, are: - Screws: scored compression screws of different diameters and several lengths. They are manufactured from titanium alloy. - Staples: of different widths, sections and leg lengths. They are manufactured from stainless steel titanium or titanium alloy.

2 - Indications:
Screws Mono and bi-cortical internal fixation Internal fixation of the carpal scaphoid bone. Weil osteotomies SCARF/chevron osteotomies Distal and proximal metatarsal osteotomies

Staples Phalangeal shortening osteotomies Proximal or distal phalangeal osteotomies Internal fixations requiring mono or bi-cortical compression.

Metatarso-phalangeal arthrodeses Arthrodeses of the middle and hind foot.

3 - Contra-indications:
Acute or chronic local or systemic infections.

- Factors liable to compromise the success of implantation:

- Intensive physical activity. - Systemic or metabolic disorders. - Allergies to implant components. - Infectious diseases. - Obesity - Severe osteoporosis. - Local bone tumours. - Tendency towards drug or alcohol abuse.

It is important that the patient is informed of these factors and the influence which they may have on the success of implantation. - Undesirable effects: Infection Allergic reactions Haematomas Venous thrombosis and pulmonary embolism. - Risk of interference with medical imaging investigations: MRI/CT SCAN. Inform the patient always to report that he/she has an implant 4 - Precaution before use:
This product is sold STERILE. Confirm the integrity of the packaging before use. It is sterilised by gamma irradiation at a minimum dose of 25 kGy (in compliance with norm ISO 11137). Confirm the integrity of the packaging (external packaging and double internal packaging) and the expiry date stated on the label on the outside of the box before use. If you have any doubt about these points please return this box to us and use another. This implant must always be handled in accordance with Good Clinical Practice.

5 Precaution for use:

The surgeon must use the ancillary instrumentation provided observing the conditions stated in the operating procedure where applicable. When handling the implants avoid any contact with foreign material liable to harm their surface state. Rectilinear PAREOS supports: it is formerly recommenced that the supports not be bent. The EOS company SARL takes no responsibility in the event of changes in the initial characteristics of the device or when its products are associated with parts of different origin.

6 Re-use:
Previously implanted products must never be reused. The EOS company takes no responsibility for reuse.

7 - Re-sterilisation of products:
Any re-sterilisation is prohibited. The EOS company takes no responsibility for reuse.

8 - Preventative procedures to avoid post-operative complications:

- Avoid forced extreme positions such as flexion/extension. - Avoid violent sports. - Avoid overweight. - Wear orthopaedic footwear following the surgeons prescriptions. - Avoid carrying heavy loads. - Ensure that a doctor treats any infection which develops either in the operated limb or in any other part of the body rapidly.

9 - Ancillary instrumentation:
Please consult the ancillary instrumentation leaflet before implantation INFORMATION: Please contact our representative or distributor, or EOS sarl directly, for any further information about products or their use.

Manufactured by the EOS company sarl ZI rue P Lebon - B.P. 26 52800 NOGENT FRANCE

Marketing department ZA des Grands Prs 26110 St Maurice sur Eygues FRANCE

0120 June 1998 Feb. 2000 March 2002

Symbol legends:

Unima Blue
IMPLANTS
References ST.P07.072.040 ST.P07.072.045 ST.P07.072.050 ST.P07.072.055 ST.P07.072.060 ST.P07.072.065 ST.P07.072.070 ST.P07.072.075 ST.P07.072.080 ST.P07.072.085 ST.P07.072.090 ST.P07.072.095 ST.P07.072.100 ST.P07.072.105 ST.P07.072.110 ST.P07.072.115 ST.P07.072.120 Description Distal thread 18mm UNIMA Blue Screw 7.2 mm Length 40 mm UNIMA Blue Screw 7.2 mm Length 45 mm UNIMA Blue Screw 7.2 mm Length 50 mm UNIMA Blue Screw 7.2 mm Length 55 mm UNIMA Blue Screw 7.2 mm Length 60 mm UNIMA Blue Screw 7.2 mm Length 65 mm UNIMA Blue Screw 7.2 mm Length 70 mm UNIMA Blue Screw 7.2 mm Length 75 mm UNIMA Blue Screw 7.2 mm Length 80 mm UNIMA Blue Screw 7.2 mm Length 85 mm UNIMA Blue Screw 7.2 mm Length 90 mm UNIMA Blue Screw 7.2 mm Length 95 mm UNIMA Blue Screw 7.2 mm Length 100 mm UNIMA Blue Screw 7.2 mm Length 105 mm UNIMA Blue Screw 7.2 mm Length 110 mm UNIMA Blue Screw 7.2 mm Length 115 mm UNIMA Blue Screw 7.2 mm Length 120 mm

References ST.P07.172.090 ST.P07.172.095 ST.P07.172.100 ST.P07.172.105 ST.P07.172.110 ST.P07.172.115 ST.P07.172.120

Description Distal thread 36 mm UNIMA Blue Screw 7.2 mm Length 90 mm UNIMA Blue Screw 7.2 mm Length 95 mm UNIMA Blue Screw 7.2 mm Length 100 mm UNIMA Blue Screw 7.2 mm Length 105 mm UNIMA Blue Screw 7.2 mm Length 110 mm UNIMA Blue Screw 7.2 mm Length 115 mm UNIMA Blue Screw 7.2 mm Length 120 mm

Unima Blue
ASSOCIATED INSTRUMENTS
AP07.033 AP07.032 AP07.022 AP07.124 AP07.125 AP07.126 AP07.117 AP07.072 K-wire guide with handle for Unima Gold & Blue Quick coupling cannulated Handle for Tape and Screwdriver Cannulated T- handle screwdriver AO 4.2 mm / 1.7 mm Unima Blue cannulated drill AO 4.2 mm Unima Blue drill Lg. 210 mm AO 4.2 mm/ 5.5mm Unima Blue cannulated one step drill UNIMA Blue 7.2 mm cannulated screwdriver Quick coupling AO cannulated Unima Blue Tape length 210 mm

AP07.120 Drilling guide for triple arthrodesis AP07.120_01 Drilling guide AP07.120_02 U body AP07.120_03 Locking screw AP07.120._04 Drilling guide for 7.2 mm Unima Blue screw AP07.120_05 K-wire guide for 7.2 mm Unima Blue screw AD010.070 Depth gauge <= 070 mm AD010.125 Depth gauge <= 125 mm AD021 K01 115 230 Sterilisation tube Lg 230mm for UNIMA Blue 7,2 mm Kwires 1,5 mm K-wire Lg. 230 mm

The products are manufactured and referenced within the frame of the standards in force. Implantation procedures are described in the surgical technique. Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. WARNING : Federal law (USA) restricts this device to sale by or on the order of a physician

Distributed by :

ZA Grands Prs Route de Nyons F-26110 ST MAURICE SUR EYGUES France Tel : + 33 ( 0 ) 4 75 28 26 71 - Fax : + 33 ( 0 ) 4 75 28 70 61 www.eos-france.com email :info@eos-France.com