MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-EDGE D/A WIRE CUTTER 7; INSTRUMENTS- CUTTING & DISSECTING

Catalog Number	275510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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
The following was reported via medwatch/mdr report # mw5179561: "during a scheduled surgery of left distal radius open reduction internal fixation on, surgeon attempted to use a wire cutter to trim a metal wire and unexpectedly they stated that the wire cutter's blade scattered into multiple pieces and fell into patient's surgical site." attempts have been made to obtain additional information regarding the selection clinical code: altered state of conscious in voluntary medwatch report.No additional information has been provided at this time.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The carb-edge d/a wire cutter 7 (275510) was not returned for evaluation after several good-faith efforts had been made to retrieve the product; therefore, an evaluation of the device could not be performed.Definitive root cause cannot be determined.The product is labeled to cut wires with a maximum diameter of 1.7 mm.Breakage may result from cutting a wire that is too thick.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CARB-EDGE D/A WIRE CUTTER 7
• Common Device Name: INSTRUMENTS- CUTTING & DISSECTING
• 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: 24036583
• Report Number: 3014334038-2026-00002
• Device Sequence Number: 15717828
• 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): 02/12/2026

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: 275510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/12/2026
• 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: Female