MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BABCOCK TISS FCPS 6-1/4; INSTRUMENTS - GRASPING

Catalog Number	135181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the babcock tiss fcps 6-1/4 (135181) was being used in a procedure when it broke.It was not known at the time of surgery that the instrument had broken.The break was discovered during instrument cleaning.Once identified, the patient was brought back to the operating room for a second surgery to retrieve the retained piece.The broken part was successfully recovered.No death or injury was reported.
Additional Manufacturer Narrative
The babcock tiss fcps 6-1/4 (135181) was not returned for evaluation.A review of the device history record (dhr) could not be performed as the lot number was not available.The purchase order history indicated this device may have been purchased in 2019.There has been no return of product for evaluation.It was indicated that the product would not be returned.Therefore, the definitive root cause cannot be determined.The issue of breaking may be the result of wear over multiple years of use or rough handling.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: BABCOCK TISS FCPS 6-1/4
• Common Device Name: INSTRUMENTS - GRASPING
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 25333944
• Report Number: 3014334038-2026-00039
• Device Sequence Number: 15917984
• Product Code: GEN
• UDI-Device Identifier: 10381780433460
• UDI-Public: 10381780433460
• 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
• Report Date (Section B): 05/29/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 135181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown