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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 05/22/2025, it was reported by a sales representative via (b)(4) that an ar-9938-11 wire cutter clamp broke.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.A visual evaluation noted that one of the silicone inserters was broken off.Laser marks that had faded and rusted were also noted.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is normal wear and tear due to continuous mechanical forces applied to the device, which will inevitably sustain damage over time.

• 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: 22282404
• Report Number: 1220246-2025-02505
• Device Sequence Number: 18361685
• Product Code: LXH
• UDI-Device Identifier: 00841435109582
• UDI-Public: (01)00841435109582(11)220819(10)672207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/29/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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