MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-EDGE FLUSH WIRE CUTTER 7; N/A

Catalog Number	275525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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
It was reported that the tip of the carb-edge flush wire cutter 7 (275525) broke and fell into the patient during a case.The broken pieces were recovered, which resulted in a 5¿10 minute delay during the procedure.A replacement wire cutter was used to complete the procedure.No patient injury, complication post-procedure, or death occurred.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The carb-edge flush wire cutter 7 (275525) was returned for evaluation.Failure analysis - the returned wire cutter were received in used condition with two of the edges chipped.The provided order number indicated the product was purchased in sept.2022.Damage to the jaws may be the result of wear or rough handling over two years of use.The two chips were on the front and side of the jaws' corners, indicating the wire was cut at the corner rather than head at the middle of the jaws.Breakage may result from cutting with the corner rather than the middle of the jaw.Root cause analysis - the reported complaint was confirmed.Breakage may be the result wear/rough handling of cutting at the corner of the jaws.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: CARB-EDGE FLUSH WIRE CUTTER 7
• 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: 20678124
• Report Number: 3014334038-2024-00215
• Device Sequence Number: 15261301
• Product Code: HXZ
• UDI-Device Identifier: 10381780385110
• UDI-Public: 10381780385110
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2024

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: 275525
• Device Lot Number: AA2201
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2022
• 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