SHARP HOOK

Additional Manufacturer Narrative

A PRODUCT INVESTIGATION WAS COMPLETED: THE PART IS BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. OUR INVESTIGATION SHOWS THAT THE ARTICLE IS OVER ALL IN A GOOD CONDITION, NEVERTHELESS THAT THE HOOK IS BROKEN OFF. MEASUREMENTS ON THE BROKEN POSITION ARE NOT POSSIBLE ABOUT THE BREAKAGE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THERE IS NO SPECIFIC INFORMATION ABOUT WHAT HAPPENED TO THIS ARTICLE WITH THE CUSTOMER; BASED ON THIS WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS PROBLEM, BUT IT IS LIKELY THAT WEAR AND TEAR FROM USE OVER THE YEARS (AS THE INSTRUMENT IS OVER 11 YEARS OLD) AND/OR HIGH APPLIED MECHANICAL FORCE, LED TO THIS DAMAGE. NO PRODUCT PROBLEM IDENTIFIED; NO PRODUCT FAULT COULD BE DETECTED. 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. UNKNOWN IF PATIENT WAS INVOLVED OR WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE 319.390 / 2101796 MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 07.JUL.2004, EXPIRY DATE: - NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN INSTRUMENT WAS BROKEN, HALF THE HOOK IS SNAPPED OFF. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).