SHARP HOOK
Received Aug 7, 2014 · Event occurred Jul 11, 2014
Report 2520274-2014-13008 · MDR key 3987019
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL RADIUS, THE TIP OF THE SHARP HOOK BROKE OFF. THE PIECE WAS RECOVERED AND THERE WAS NO DELAY IN SURGERY OR HARM TO THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).