MAUDE Adverse Event Report: ARTHREX, INC. .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	.062 WIRE CUTTER W/ SAFTY INSRT, ANGLED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-9938-11 wire cutter broke.This occurred during an orif ankle procedure on (b)(6) 2024 after placing a snap-off compression ft pin, the surgeon tried to clip the remaining implant with the pin cutter and the pin cutter broke.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 see attached vendor evaluation.

• Brand Name: .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20188698
• Report Number: 1220246-2024-07503
• Device Sequence Number: 8250063
• Product Code: LXH
• UDI-Device Identifier: 00841435109582
• UDI-Public: 00841435109582
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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 Model Number: .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED
• Device Catalogue Number: AR-9938-11
• Device Lot Number: 672207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown