MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, BIOCOMPOSITE; BONE FIXATION SCREW/PLATE

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 13-mar-2026, a facilities representative reported via phone that an ar-1540bc biocomposite tenodesis screw fell apart when tapped at the initial point of insertion during an open reduction and internal fixation of a scaphoid fracture.All fragments were retrieved, and a new device was opened to complete the case with a minimal time delay.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 24793544
• Report Number: 1220246-2026-01971
• Device Sequence Number: 13222747
• Product Code: HWC
• UDI-Device Identifier: 00888867018709
• UDI-Public: (01)00888867018709(11)260119(17)271231(10)15560616
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1540BC
• Device Lot Number: 15560616
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• 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