SHARP HOOK L155

Description of Event or Problem

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: THE TIP OF THE HOOK SNAPPED OFF DURING USE; IT IS UNCLEAR IF THE BROKEN PORTION WAS RETRIEVED. IT WAS NOT REPORTED THAT THE CASE WAS PROLONGED OR CAUSED ANY ADVERSE INCIDENTS. ONLY THE (B)(6) IS INDICATED ON THE RETURNED DEVICE INDICATED IN THIS EVENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. : PLACEHOLDER.

Additional Manufacturer Narrative

(B)(4): IT WAS NOT POSSIBLE TO IDENTIFY THE RETURNED ARTICLE. BASED ON THE DIMENSIONS THE DEVICE SEEMS TO BE THE PART NUMBER 319.390 AS INDICATED IN THE DEVICE REPORT. (B)(4). IF THIS IS A LOT NUMBER IT IS COMPLETELY UNKNOWN AT SYNTHES. WE WERE ABLE TO TRACE BACK THE LOT NUMBER TO THE LOT NUMBER 2008, WHICH WAS MANUFACTURED IN THE YEAR 1983. BASED ON THAT IT IS POSSIBLE THAT THIS ARTICLE IS EITHER OLDER THAN 30 YEARS OR THAT IT IS NOT A SYNTHES DEVICE. THE VISUAL INSPECTION HAS SHOWN THAT THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THERE ARE SOME STRONG STRESS MARKS VISIBLE AT THE REMAINDER OF THE TIP, WHICH COULD BE AN INDICATION FOR A MECHANICAL OVERLOAD.