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

Model Number 275510

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 307790381
• Report Number: 3014334038-2022-00280
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10381780385097
• UDI-Public: 10381780385097
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/06/2023
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1