TAP FOR RECON SCREWS / Ø 6.5MM
Received Jun 22, 2026 · Event occurred Jan 1, 2026
Report 8030965-2026-06442 · MDR key 25584396
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN UTILIZING THE ANS BASE INSTRUMENT SET AND THE TFNA STANDARD SETS, NUMEROUS ITEMS BROKE/BECAME FAULTY THAT CAUSED APPROXIMATELY 15 MINUTES OF SURGICAL DELAY. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL 10-15 SECONDS OF FLUOROSCOPY WAS REQUIRED TO ASSIST WITH THE SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED UNDER RELATED COMPLAINT (B)(4).
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. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.