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

Model Number	DRIVER, BIOCOMPOSITE QUICK CONNECT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 06 august 2026, it was reported by a sales representative via email that an ar-4030c-09, 9x 30mm bc if scrw vented was reported to be broken.Dr was inserting the interference screw ar-4030c-09 lot 15231892 with the screwdriver from our tray and the screw broke.This occurred on (b)(6) 2026 during an unknown procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DRIVER, BIOCOMPOSITE QUICK CONNECT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50379946
• Report Number: 1220246-2026-04455
• Device Sequence Number: 9884092
• Product Code: LXH
• UDI-Device Identifier: 00888867025714
• UDI-Public: 00888867025714
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/21/2026

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: DRIVER, BIOCOMPOSITE QUICK CONNECT
• Device Catalogue Number: AR-1996CD-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown