SHARP HOOK

Additional Manufacturer Narrative

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REPORTED DIENER (B)(4) MANUFACTURED THE SHARP HOOK, PART #388.424, AND LOT #4251636 (SUPPLIER LOT #A7KA12) ON PO #(B)(4), FOR (B)(4) PIECES DELIVERED APRIL 3, 2001. INITIALLY, THE PART CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #(B)(4), REVISION ¿B.¿ THE PARTS WERE RELEASED TO THE WAREHOUSE ON APRIL 3, 2001. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE SHARP HOOK WAS MADE TO THE SYNTHES DRAWING P/N 319.39, REVISION ¿E¿, RELEASED ON MARCH 17, 2000. 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 PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT ONE SHARP HOOK (PART# 319.39, LOT# A7KA12, MFG APR2001) WAS RETURNED WITH THE COMPLAINT THAT ¿IT WAS REPORTED THAT PIECES HAD BROKEN OFF PART NUMBERS 338.23 (6), 319.091, 319.39 AND 03.900.002. IT WAS UNKNOWN HOW THE PARTS BROKE.¿ UPON RECEIPT OF THIS DEVICE THE COMPLAINT WAS CONFIRMED AS THIS SHARP HOOK IS MISSING THE DISTAL 2MM OF THE POINT, THE REMAINDER OF THE DEVICE IS IN GOOD CONDITION. THE MOST RECENT DRAWING FOR THIS DEVICE (319_39 REV J) ALONG WITH THAT TO WHICH THE DEVICE WAS MANUFACTURED (319_39 REV E) WERE REVIEWED AND THE DESIGN, MATERIAL AND FINISHING PROCESS WERE DETERMINED TO BE ADEQUATE FOR THE INTENDED USE OF THIS DEVICE, CHANGES BETWEEN THE CURRENT DRAWING AND THE DESIGN OF THIS LOT ARE IN REGARDS TO ETCHINGS. 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 EXCESSIVE FORCE WAS APPLIED TO THIS DEVICE CAUSING THIS FAILURE. THE COMPLAINT FOR THIS PART IS CONFIRMED. THE COMPLAINT WAS LIKELY A RESULT OF EXCESS FORCE BEING APPLIED TO THE TIP OF THIS INSTRUMENT. 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.

Description of Event or Problem

IT WAS REPORTED THAT PIECES HAD BROKEN OFF OF NINE DEVICES. IT WAS UNKNOWN HOW THE PARTS BROKE. NO ADDITIONAL INFORMATION WAS REPORTED. NO PATIENT INVOLVED. THIS IS REPORT 7 OF 9 FOR (B)(4).