3.5MM VA DRILL GUIDE
Received May 18, 2026 · Event occurred May 11, 2026
Report 8030965-2026-04640 · MDR key 25201017
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CABLE TENSIONER WAS NOT WORKING CORRECTLY WHICH MEANT THEY HAD TO CUT THE CABLE OFF THE PLATE AND START AGAIN WITH A DIFFERENT CABLE AND TENSIONER. THE VA DOUBLE DRILL GUIDE ALSO BROKE WHILST THE SURGEON WAS TRYING TO REMOVE THE GUIDE FROM THE PLATE. THIS DELAYED THE OPERATION BUT APPROXIMATELY 15 MINUTES.
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 LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.