MalfunctionGDG
HOOK, WEARY NERVE, BLUNT, FINE, BLACK FINISH, 7 3/4 IN
Received Jul 14, 2025 · Event occurred May 27, 2025
Report 3007208013-2025-00035 · MDR key 22501339
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
53 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED (HOSPITAL/USER INFORMATION, CONTACT DETAILS, ADDITIONAL EVENT NARRATIVE) BASED ON INFORMATION PROVIDED IN MEDWATCH REPORT. WITHOUT THE ABILITY TO CONTACT THE USER OR HOSPITAL, ADDITIONAL INVESTIGATION IS NOT POSSIBLE. THIS REPORT SERVES AS BOTH INITIAL AND FINAL REPORTS TO FDA.
Description of Event or Problem
COMPLAINANT ALLEGES, "THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT DURING SURGERY."