SHARP HOOK
Received Apr 26, 2013 · Event occurred Oct 27, 2011
Report 8030965-2013-11092 · MDR key 3079865
Device
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(6) 2011. PLACEHOLDER.
Description of Event or Problem
IT WAS REPORTED THAT A SURGEON WAS PERFORMING A KNEE SCOPE AND THE TIP OF THE SHARP HOOK BROKE OFF IN THE PATIENT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS REPORT IS FOR (B)(4).
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE TIP WAS BROKEN OFF. THE CUTTER CORRESPONDED TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. IT WAS DETERMINED THAT TOO MUCH FORCE WAS APPLIED TO THE TIPS, CAUSING ONE TO BREAK. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.