SNAP CLAMP ASSEMBLY
Received Feb 5, 2026
Report 3004608878-2026-00002 · MDR key 24267958
Device
Generic name
Omni-tract
Manufacturer
Integra Lifesciences Corporation Oh/usaCatalog number
4040
Lot number
147
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SNAP CLAMP ASSEMBLY (4040) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE EVALUATION SHOWS THAT THE BOLT HAS SHIFTED, AND THE SNAP CLAMP WAS NOT CLOSING PROPERLY AS A RESULT. THE BOLT MUST BE REPLACED ALONG WITH THE WORN WASHERS, AND THE UNIT MUST BE READJUSTED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. THE LARGER CLAMP (0.500) SHOWS SCRATCHES ON THE RUNNING SURFACE AND MUST BE REPLACED TO PREVENT DAMAGE TO THE BLADES. PRODUCT WEAR AND TEAR DUE TO NORMAL USE IS EXCLUDED FROM THE TERMS OF THE OMNI TRACT WARRANTY. ROOT CAUSE: BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE IS MOST LIKELY ROUGH OR IMPROPER HANDLING OF THE DEVICE.
Description of Event or Problem
A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE, THE SNAP CLAMP ASSEMBLY (4040) EXHIBITED A DEFECT, WHICH WAS A TIGHTENING PROBLEM ON THE HOOP THAT RESULTED IN A 30-MINUTE DELAY IN SURGICAL TIME. ANOTHER SURGICAL INSTRUMENT WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR DEATHS WERE REPORTED.