MalfunctionHTW
GSOURCE
Received Oct 29, 2025 · Event occurred Aug 19, 2025
Report 2249529-2025-00005 · MDR key 23419729
Device
Product problems
- Break
- Break
Patient
76 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
A DRILL BIT BROKE WHILE PERFORMING A TOTAL HIP ARTHROPLASTY.
Additional Manufacturer Narrative
THE FOLLOWING DETAILS THE INVESTIGATION OF BREAKAGES OF DRILL BIT SQC 2.0MM 125/21.5MM. AFTER COMMUNICATING WITH THE HEALTHCARE PROFESSIONAL, THE LOT NUMBER OR COMPLAINT PART WERE NOT AVAILABLE. BASED ON LITERATURE, THE SMALLER DRILL BIT SIZE IS NOT RECOMMENDED FOR USE IN TOTAL HIP ARTHROPLASTY PROCEDURES. BASED ON INTERNAL TESTING IT DOES NOT APPEAR TO BE A PRODUCT DESIGN RELATED ISSUE. HOWEVER, THE DESIGN WAS IMPROVED TO MAKE IT MORE ROBUST.