MAUDE Adverse Event Report: ARTHREX, INC. 2.9MM BIOCOMPOSITE PUSHLOCK KIT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	2.9MM BIOCOMPOSITE PUSHLOCK KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 1/30/2024, it was reported by an arthrex subsidiary employee via email that an ar-2923bc-k implant system biocomposite pushlock anchor pulled out after insertion.A 2.9 pushlock drill bit was used to prepare the bone socket.All broken parts were retrieved from the patient, and the case was completed using another ar-2923bc-k from an unknown lot.There was no case delay and no additional anesthesia administered.This was discovered during a bankart procedure on (b)(6) 2023, with no patient harm reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided, including the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the cause of the reported failure was a user error, improper bone preparation, and misalignment of the insertion.The complaint allegation was not confirmed.The device was not received for evaluation, and the customer¿s attached picture does not provide evidence of the failure.

• Brand Name: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 18730802
• Report Number: 1220246-2024-01025
• Device Sequence Number: 12526541
• Product Code: MAI
• UDI-Device Identifier: 00888867224117
• UDI-Public: 00888867224117
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101679
• 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): 06/04/2025

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 Expiration Date: 07/31/2025
• Device Model Number: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• Device Catalogue Number: AR-2923BC-K
• Device Lot Number: 15133979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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