SHARP HOOK

Additional Manufacturer Narrative

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN IF PATIENT WAS INVOLVED, PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. OTHER UDI: (B)(4) LOT UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INITIAL REPORTER FACILITY PHONE NUMBER: (B)(6). PMA 510K# UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DRILL SLEEVE HAD ALREADY HAD THE BROKEN TIP AT THE TIME OF DELIVERY TO A THIRD-PARTY (EXTERNAL) DISTRIBUTOR. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

Additional Manufacturer Narrative

MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 09, 2014. NEITHER DEVIATION NOR ANY NON-CONFORMANCE REPORTS WERE MARKED IN THE DEVICE HISTORY RECORD. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER MARKING WAS READABLE. TRACES OF REPEATED USE WERE VISIBLE. DUE TO THE BROKEN TIP, THE DIMENSIONS OF THE SHARP HOOK, RELEVANT FOR THE FUNCTION, AND DRAWING CANNOT BE MEASURED. THE HARDNESS OF THE HOOK WAS MEASURED AND IT MEETS THE SPECIFICATION. THE MATERIAL CERTIFICATES MEET THE SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT, OF THE END PRODUCT AND ALSO FOR ITS COMPONENT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. IT IS LIKELY THAT THE TIP BROKE DUE TO REPEATED USE OF THE INSTRUMENT. THE EXACT ROOT CAUSE COULD NOT BE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.