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	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025 , it was reported by a sales representative via (b)(4) that an ar-9938-11 wire cutter broke while trying to cut the snap off pins.This was discovered during the case with no 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: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9938-11 batch 672331 was received for investigation.Visual inspection found that a piece of the device's jaws was broken off, and the silicon inserter was not returned for evaluation.The device shows discoloration spots.Functional testing was performed by pressing the handle to check for resistance or any issues.The most likely cause of the reported failure is user error, applying excessive force during use.

• 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: 21867056
• Report Number: 1220246-2025-01585
• Device Sequence Number: 4720866
• Product Code: LXH
• UDI-Device Identifier: 00841435109582
• UDI-Public: (01)00841435109582(11)240130(10)672331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/12/2025

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: 672331
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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