SHARP HOOK
Received Mar 20, 2013 · Event occurred Feb 27, 2012
Report 8030965-2013-10574 · MDR key 3013931
Device
Product problems
- Break
- Sticking
Patient
Not reported
- No Consequences Or Impact 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. THE DEVICE HISTORY RECORD WAS NOT ARCHIVED, INSTRUMENT IS NEARLY 7 YEARS OLD. THE MANUFACTURING EVALUATION SHOWED THAT THE TIP WAS EXTREMELY DEFORMED. THE SHARP HOOK CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. TOO MUCH FORCE WAS APPLIED TO THE TIP CAUSING IT TO BEND. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID.
Description of Event or Problem
THIS IS REPORT 1 OF 2 FOR COMPLAINT (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. ORIGINAL AWARENESS DATE IS (B)(4) 2012.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ANKLE FRACTURE PROCEDURE, THE TIP OF THE SHARP HOOK (319.39) BROKE WHILE THE SURGEON WAS REDUCING THE FRACTURE. THE BROKEN FRAGMENT WAS RETRIEVED. DURING THE PROCEDURE, THE UNIVERSAL CHUCK WITH T-HANDLE BECAME STUCK. THE SCHANZ PIN IN THE UNIVERSAL CHUCK WITH T-HANDLE AND IT WOULD NOT COME APART. SURGEON USED ANOTHER SHARP HOOK AND UNIVERSAL CHUCK WITH T-HANDLE TO COMPLETE THE PROCEDURE WITH NO HARM TO PATIENT. THIS IS REPORT 1 OF 2 FOR THIS EVENT.