MAUDE Adverse Event Report: ARTHREX, INC.; MANUAL INSTR, GENERAL SURGICAL

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04-feb-2026, it was reported by n arthrex subsidiary employee via (b)(4) that an ar-12990 knee scorpion had a broken needle in the instrument and was not working properly.No case involvement was reported.Additional information provided 06-feb-2026: it was further reported this discovered during use in a procedure with no patient harm.When attempting to use the instrument, it was not possible to do so, and the case was completed with another device.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNK
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24400248
• Report Number: 1220246-2026-00691
• Device Sequence Number: 8158899
• Product Code: MDM
• UDI-Device Identifier: 00888867196322
• UDI-Public: (01)00888867196322(11)240527(10)15254136
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown