MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRILE FCPS 5-1/2 CVD SATIN; N/A

Catalog Number	106121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 5-1/2 curved satin crile forceps (106121) was not returned to the manufacturer; therefore, an evaluation of the physical device could not be performed.Lot number information was provided; manufacturing records were reviewed and found no anomalies.Per visual evaluation of the provided images, the crile forceps had one of the jaws sheared off.Damage to the jaws may be the result of rough handling or environmental damage.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
A facility reported that during a cardiac procedure, the jaws of the 5-1/2 curved satin crile forceps (106121) broke off into the patient's operative site.The broken part was retrieved.No patient injury, death, or surgical delay was reported.

• Brand Name: CRILE FCPS 5-1/2 CVD 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: 22392006
• Report Number: 3014334038-2025-00094
• Device Sequence Number: 13016101
• Product Code: HRQ
• UDI-Device Identifier: 10381780164524
• UDI-Public: 10381780164524
• 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): 07/03/2025

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: 106121
• Device Lot Number: AS2411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 07/03/2025
• 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
• Patient Sex: Unknown