UNK - DRILL BITS: TRAUMA
Received Jun 26, 2026 · Event occurred Jun 4, 2026
Report 8030965-2026-06631 · MDR key 25634143
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. IT WAS REPORTED BY THE AGENCY THAT THE DRILL BROKE OFF AT THE HAND SURGERY. DETAILS ARE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INVESTIGATION OF THE BROKEN DRILL WAS REQUESTED. IT WAS REPORTED THAT THE SURGEON WOULD LIKE TO KNOW WHETHER ANY FRAGMENTS OF THE BROKEN DRILL REMAINED INSIDE THE PATIENT'S BODY. NO FURTHER INFORMATION IS AVAILABLE.