MAUDE Adverse Event Report: ARTHREX, INC. AVN DISPOSABLES KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVN DISPOSABLES KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an avascular necrosis surgery, the reverse drill did not work.There is no possibility to adjust the drill extension.There is no possibility to retract the drill.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device from the kit.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Update (b)(6) 02-jun-2025 further information was received that clarifies the issue: after inserting the drill bit through the sleeve, the surgeon had a problem with the correct operation of the blade.The blade did not open properly.The surgeon had trouble getting the drill bit out of the sleeve but eventually succeeded.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3519h batch 15235904 was received for evaluation.Functional testing was performed by moving the selector sleeve; it was noted that the cutting blade was not moving.Visual evaluation revealed that the cutting blades have nicks, suggesting the possibility that material may be missing from the blades due to the damage.The most likely cause of the reported failure is user error, including improper bone preparation, bending, and/or the use of excessive force during use.

• Brand Name: AVN DISPOSABLES KIT
• 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: 22106749
• Report Number: 1220246-2025-02279
• Device Sequence Number: 20886868
• Product Code: LXH
• UDI-Device Identifier: 00888867266643
• UDI-Public: (01)00888867266643(11)240417(17)290331(10)15235904
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: AVN DISPOSABLES KIT
• Device Catalogue Number: AR-3519H
• Device Lot Number: 15235904
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 08/13/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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