MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
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 07/09/2024, it was reported by an arthrex subsidiary employee via email that two ar-1547cds biocomposite-tenodesis loop at the tip of the screws broke.When attempting to fix the graft and suture tape together to the talus, the graft deviated during the process, and when the product was checked, the tip loop was broken.A second ar-1547cds biocomposite-tenodesis was opened and implanted successfully.However, after the implantation of the screw, it was noticed that the loop at the tip of the inserter had broken.This was discovered during a procedure on (b)(6) 2024.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• 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: 19828539
• Report Number: 1220246-2024-06903
• Device Sequence Number: 12640944
• Product Code: HWC
• UDI-Device Identifier: 00888867233959
• UDI-Public: 00888867233959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051726
• 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): 06/19/2025

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: 03/31/2025
• Device Model Number: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• Device Catalogue Number: AR-1547CDS
• Device Lot Number: 15085846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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