MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SNAP CLAMP ASSEMBLY; OMNI-TRACT

Catalog Number	4040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: SNAP CLAMP ASSEMBLY
• Common Device Name: OMNI-TRACT
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24267958
• Report Number: 3004608878-2026-00002
• Device Sequence Number: 21319128
• Product Code: FFO
• UDI-Device Identifier: 10381780270638
• UDI-Public: 10381780270638
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4040
• Device Lot Number: 147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown