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

Catalog Number	4040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
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
A facility reported that during a "highly complex digestive surgery involving a pancreaticoduodenectomy with vascular resection", the snap clamp assembly (4040) "spontaneously broke while being manipulated." the broken retractor did not fall into the surgical site, and all broken parts were successfully recovered.There was no injury to the patient; however, a surgical delay of two hours was reported.
Additional Manufacturer Narrative
The snap clamp assembly (4040) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.The device history record (dhr) was reviewed.The dhr documented a nonconformance; the affected components were reworked, and the rework was confirmed to have no adverse effect on the product.A photo of the suspected product was provided by the customer.Investigation of the picture confirms the fracture.It was likely caused by mishandling leading to the clamp being subjected to higher stress than it was intended to be able to withstand.No relevant corrective actions were discovered.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The snap clamp assembly (4040) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.The analysis of the clamp found that it contains significant corrosion on the internal clamp surfaces, as seen in the attached picture.This retractor was reportedly used on other occasions.Based on this and based on analysis of the returned clamp, it is most likely that improper/inadequate drying following the cleaning and/or sterilization process caused the clamp to corrode, leading to the weakening and ultimately the fracture of the clamp in the location of the corrosion.The 4040 snap clamps must be thoroughly dried following the washing and sterilization process as per instruction for use (ifu) 40-9015 to prevent residual water from corroding the 4040 snap clamps.
Event or Problem Description
N/a.

• 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: 21532619
• Report Number: 3004608878-2025-00041
• Device Sequence Number: 7055300
• 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): 07/14/2025

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: 6229328
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 07/11/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/13/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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