MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT FOR 2.9MM PUSHLOCK; MANUAL INSTR, GENERAL SURGICAL

Model Number	DISPOSABLE KIT FOR 2.9MM PUSHLOCK
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1923ds disposables kit drill was not as sharp as usual, so the doctor stopped using it and opened another one of the same products, which allowed him to complete the procedure without any problems.This occurred during use in a case with no patient effect.
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 device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically misalignment of the instrument during use.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• 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: 23335642
• Report Number: 1220246-2025-04692
• Device Sequence Number: 9937563
• Product Code: MDM
• UDI-Device Identifier: 00888867023079
• UDI-Public: (01)00888867023079(11)240426(17)290331(10)15240455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 02/25/2026

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
• Device Model Number: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• Device Catalogue Number: AR-1923DS
• Device Lot Number: 15240455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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