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

Model Number	DISPOSABLES KIT FOR 2.9MM SHORT PUSHLOCK
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 03/28/2023 by an arthrex employee via (b)(4) that an ar-2923ds disposables kit axis was shifting when used.Upon checking, burrs were observed at the rear of the drill.Used a new product, and the case was completed.This occurred during use with no patient harm.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Upon visual evaluation, it was noted one of the drills for the 2.9mm push lock has depth abrasion marks and laser marks were erased around the outside diameter of the drill.The most likely cause of this condition is excessive force/friction during use or insertion.The cause remains error use.Functional testing identified that the returned device does not work as required.

• Brand Name: DISPOSABLES KIT FOR 2.9MM SHORT 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: 19372882
• Report Number: 1220246-2024-03660
• Device Sequence Number: 15379460
• Product Code: MDM
• UDI-Device Identifier: 00888867099210
• UDI-Public: 00888867099210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: DISPOSABLES KIT FOR 2.9MM SHORT PUSHLOCK
• Device Catalogue Number: AR-2923DS
• Device Lot Number: 15061613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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