MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,BIO-COMP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/21/2024 it was reported by a sales representative via email that an ar-1547bc biocomposite tenodesis screw was implanted during a tibialis anterior tendon transfer procedure on (b)(6) 2024.The surgeon whip-stitched the tibialis anterior tendon, then drilled through the bone with a 2.4 mm guide pin and reamed with a 4.0 mm reamer.The surgeon docked the tendon and inserted the ar-1547bc biocomposite tenodesis screw.Upon releasing the hold on the patient's foot, the tendon snapped.The surgeon stated the screw cut through the tendon and removed the screw.The patient's tissue quality was healthy.To complete the repair, the surgeon re-whip-stitched the graft docked into the bone socket and tied sutures over a 12 mm button.
Event or Problem Description
Additional information: the part number for the screw used to complete the case successfully was an ar-8922 12mm suture button.Minimal additional time was added to the case to repass the tendon into the bone socket.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on visual analysis of the ar-1547bc, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to failure to ensure the screw sits flush with the cortex as per flexor digitorum longus tendon transfer with dx button and tension-slide technique.

• Brand Name: TENO SCRW,BIO-COMP
• 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: 19709222
• Report Number: 1220246-2024-06675
• Device Sequence Number: 16928161
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: 00888867018778
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 13674392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown