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	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/10/2025, it was reported by a sales representative via (b)(6) that an ar-9938-11.062 wire cutter was broken.The case was completed successfully, and no pieces broke off inside the patient.This was discovered during a talar oats procedure on 04/07/2025, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Due to photographic evidence provided from the field of an ar-9938-11, with batch number 672207, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device 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: 21936834
• Report Number: 1220246-2025-01802
• Device Sequence Number: 5342936
• Product Code: LXH
• UDI-Device Identifier: 00841435109582
• UDI-Public: (01)00841435109582(11)220819(10)672207
• 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): 07/11/2025

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
• Distributor Facility Aware Date: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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