HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR
Received Apr 29, 2026 · Event occurred Apr 14, 2026
Report 8030965-2026-03982 · MDR key 25027002
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Synthes GmbhCatalog number
395.460
Lot number
2404524
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 ON (B)(6) 2026 THAT THE WING NUTS HAVE BROKEN IN 4 OF THE SLEEVES FOR DISTRACTORS. NO PATIENT INVOLVEMENT.