MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,PEEK,VENT; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,PEEK,VENT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 29-dec-2025, a sales representative reported via email that the threads of an ar-1555ps peek tenodesis screw (5.5 x 15 mm) separated during insertion.The case was completed by opening a second screw, which was inserted without issue.This occurred during a lateral ankle reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 31-dec-2025: during insertion, the threads of an ar-1555ps peek tenodesis screw (5.5 x 15 mm) separated and broke off inside the patient.All fragments were retrieved.The case was delayed approximately five minutes, with no additional anesthesia administered.The procedure was completed using a new ar-1555ps peek tenodesis screw (5.5 x 15 mm).No adverse effects were reported during or following the procedure.
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.The complaint allegation is confirmed based on photographic evidence of an ar-ar-1555ps, batch 15241771, that displays a damaged screw.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 preparation and/or prying/leveraging the screw during insertion.

• Brand Name: TENO SCRW,PEEK,VENT
• 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: 24043569
• Report Number: 1220246-2026-00175
• Device Sequence Number: 9010603
• Product Code: HWC
• UDI-Device Identifier: 00888867018877
• UDI-Public: (01)00888867018877(11)240430(17)290331(10)15241771
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1555PS
• Device Lot Number: 15241771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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