BLADE/SCREW GUIDE SLEEVE
Received Jun 3, 2026 · Event occurred May 9, 2026
Report 8030965-2026-05097 · MDR key 25373936
Device
Generic name
Guide, Surgical, Instrument
Manufacturer
Synthes GmbhCatalog number
03.037.017
Lot number
9533341
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.
Description of Event or Problem
IT WAS REPORTED THAT THE GUIDE SLEEVE WILL NO LONGER ENGAGE ALL THE WAY DOWN AND THERE WERE SOME METAL SHAVINGS ON THIS THAT ARE BELIEVED TO BE FROM THE INNER SLEEVE.