MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SNAP CLAMP ASSEMBLY; SURGICAL RETRACTOR

Catalog Number	4040
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility engineer reported that the clamping force of the snap clamp assembly (4040) on the retractor rod was "too low, that the clamp yields to tissue pressure." there was no patient injury; however, a surgical delay exceeding 30 minutes was reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The snap clamp assembly (4040) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue was observed.Failure analysis: the customer's statement was confirmed as valid after evaluating the device."the inspection of the snap clamp reveals that it is not closing properly and has become loose.The bolt must be replaced along with the worn washers, and the unit must be readjusted according to the manufacturer's specifications.Product wear and tear due to normal use is excluded from the terms of the omni-tract warranty.This repair is not covered by the warranty.The unit must be functionally checked and marked with the instance number (b)(4)." root cause analysis: the reported complaint was confirmed.Based on the evaluation by integra service and repair, the root cause is most likely heavy wear and mishandling over time, resulting in function-inhibiting damage.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue was observed.Could not be performed at this time as not enough lot/serial/manufacture date information was provided.The number provided is only a lot code.The dhr may be reviewed, if necessary, if/when enough further information is provided or can be identified.

• Brand Name: SNAP CLAMP ASSEMBLY
• Common Device Name: SURGICAL RETRACTOR
• 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: 22375287
• Report Number: 3004608878-2025-00139
• Device Sequence Number: 8091610
• Product Code: GAD
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 09/08/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/28/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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