SHARP HOOK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE DEVICE HISTORY REPORT SHOWS, THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCES OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE SHARP HOOK WAS MADE TO THE SYNTHES DRAWING P/N 319.39, RELEASED ON MARCH 17, 2000. (B)(4) MANUFACTURED THE SHARP HOOK, PART #388.424, AND LOT #A7KA43 ON PO #(B)(4), FOR 250 PIECES DELIVERED NOVEMBER 2, 2001 (SYNTHES LOT #4338944) AND ON PO #(B)(4), FOR 300 PIECES DELIVERED NOVEMBER 2, 2001 (SYNTHES LOT #4340709). INITIALLY, THE PART CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET. THE PARTS WERE RELEASED TO THE WAREHOUSE ON NOVEMBER 2, 2001 (SYNTHES LOT #4338944) AND ON NOVEMBER 5, 2001 (SYNTHES LOT #4340709). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. SHARP HOOK, PART NUMBER 319.39, LOT NUMBER A7KA43, WAS RETURNED WITH THE COMPLAINT THAT ¿THE SHARP HOOK INSTRUMENT SMALL FRAG SET HAD A BROKEN TIP.¿ UPON RECEIPT OF THE DEVICE IT WAS SEEN THAT THE SHARP HOOK IS MISSING THE DISTAL TIP AT THE REGION WITH THE DISTAL BEND. THIS COMPLAINT IS CONFIRMED. THE MOST RECENT DRAWING FOR THE SHARP HOOK ALONG WITH THAT TO WHICH THE DEVICE WAS MANUFACTURED WAS REVIEWED AND THE DESIGN, MATERIAL AND FINISHING PROCESS WERE FOUND TO BE ADEQUATE FOR THE INTENDED USE OF THIS DEVICE. THIS DEVICE IS FOUND IN A RANGE OF SYSTEMS AND IS DESIGNED FOR LIGHT DUTY LOADING APPLICATIONS (SUCH AS REPOSITIONING FRAGMENTS, CHECKING ALIGNMENT OF FRACTURE ENDS AND REMOVING INGROWN TISSUE FROM SCREW HEADS). IT IS MOST LIKELY THAT GIVEN THE AGE OF THE DEVICE USE OVER TIME CONTRIBUTED TO THIS CONDITION, OR EXCESSIVE FORCE WAS APPLIED TO THIS DEVICE CAUSING THIS FAILURE. THE ROOT CAUSES FOR THE COMPLAINT AGAINST THE DEVICE IS UNDETERMINED. IT IS LIKELY THAT EXCESSIVE FORCE OR REGULAR USE OVER TIME CONTRIBUTED TO THE COMPLAINT CONDITION. THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITIONS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT THE SALES CONSULTANT PICKED UP A SET WITH A BROKEN INSTRUMENT. IT WAS FOUND THAT THE SHARP HOOK INSTRUMENT SMALL FRAG SET HAD A BROKEN TIP. IT IS UNKNOWN EXACTLY WHEN THE PROBLEM OCCURRED WITH THE DEVICE. THE SALES CONSULTANT FOUND OUT ABOUT THE INCIDENT ON (B)(6) 2015, THE ISSUES WERE NOTICED DURING STERILIZATION AND THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).