MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, BIOCOMPOSITE QUICK CONNECT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, BIOCOMPOSITE QUICK CONNECT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/9/2024 it was reported by a sales representative via email that an ar-1996cd-1 biocomposite interference screw driver had bioburden stuck in the cannulation and could not tighten an ar-4030c-08 fastthread biocomposite interference screw.This was discovered during a procedure on (b)(6) 2024.Additional information received on 12/19/2024: this was discovered when the guidewire was attempted to be inserted in the ar-1996cd-1 biocomposite interference screw, it was noticed the driver had bioburden stuck in the cannulation.The procedure performed was an aclr.The case was completed using a screw from another manufacturer, as there were no other drivers available.The case was delayed ten minutes without administering additional anesthesia.
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 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the driver while engaged with the screw.

• Brand Name: DRIVER, BIOCOMPOSITE QUICK CONNECT
• 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: 21071825
• Report Number: 1220246-2025-09200
• Device Sequence Number: 3409945
• Product Code: LXH
• UDI-Device Identifier: 00888867025714
• UDI-Public: 00888867025714
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/11/2025

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: DRIVER, BIOCOMPOSITE QUICK CONNECT
• Device Catalogue Number: AR-1996CD-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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