MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD OCHSNER FCPS 8 STR SATIN; N/A

Catalog Number	106220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ochsner fcps 8 str satin (106220) was returned for evaluation: failure analysis: the returned 106220 forceps were in used condition.Upon visual inspection, the ochsner forceps had one of the jaws sheared off due to rough handling or environmental damage.The device history record (dhr) will not show manufacturing abnormalities, therefore a dhr review was not performed.Root cause analysis: the reported complaint was confirmed.The returned ochsner fcps 8 str satin (106220) had one of the jaws sheared off due to rough handling or environmental damage.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
A facility reported that during a total knee replacement, the ochsner fcps 8 str satin (106220) broke at the jaw.The broken jaw was recovered, and another instrument was used to complete the surgery.No injuries, deaths, or surgical delays were reported.

• Brand Name: OCHSNER FCPS 8 STR SATIN
• Common Device Name: N/A
• 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: 22501491
• Report Number: 3014334038-2025-00101
• Device Sequence Number: 20586340
• Product Code: HRQ
• UDI-Device Identifier: 10381780023845
• UDI-Public: 10381780023845
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 106220
• Device Lot Number: AF2404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/14/2025
• 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