MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-EDGE D/A WIRE CUTTER 7; CARDIOVASCULAR BONE

Model Number	275510
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
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 there were instances using the carb-edge d/a wire cutter 7 (275-510) where they were cutting a k-wire and it frayed at the ends of the k-wire or small fragments broke off into the patient during surgery.The broken piece was recovered.No patient injury occurred; however, there was an unspecified delay in surgery time.
Additional Manufacturer Narrative
The suspected carb-edge d/a wire cutter 7 (275510) was not returned for evaluation; therefore, an evaluation of the actual device could not be performed.Lot number has been provided, device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The reported lot number indicates a manufacture date of 2016.A definitive root cause could not be determined.The issue of fragments breaking off may be the result of wear or damage over time.

• Brand Name: CARB-EDGE D/A WIRE CUTTER 7
• Common Device Name: CARDIOVASCULAR BONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15996593
• Report Number: 3014334038-2022-00280
• Device Sequence Number: 14933181
• Product Code: HXZ
• UDI-Device Identifier: 10381780385097
• UDI-Public: 10381780385097
• 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,Followup
• Report Date (Section B): 01/13/2023

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 Model Number: 275510
• Device Catalogue Number: 275510
• Device Lot Number: 10084-1601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/13/2023
• Date Device Manufactured: 01/01/2016
• 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