SHARP HOOK
Received Feb 26, 2013 · Event occurred Feb 6, 2011
Report 8030965-2013-10183 · MDR key 2987240
Device
Manufacturer
Synthes TuttlingenCatalog number
319.39
Product problems
- Break
- Detachment Of 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 ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. W/O A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS REC'D.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ON AN ANKLE THE TIP OF THE SHARP HOOK BROKE OFF. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PT. SURGEON USED ANOTHER INSTRUMENT AND COMPLETED PROCEDURE SUCCESSFULLY WITH NO EXTRA TIME.