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

Model Number	PEEK TENO SCRW,PEEK,VENT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/14/2025, it was reported by a sales representative via email that an ar-1549ps tenodesis screw, peek, vented, 4 x 10 mm broke in half upon insertion to the bone tunnel.The pieces were extracted and an additional ar-1549ps tenodesis screw was opened to complete the case.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 02/25/2025: there was no case delay, and no added anesthesia was administered to the patient.No adverse effects were reported during or after the surgery.This was discovered during a scapholunate stabilization procedure on (b)(6) 2025.
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.Photographic evidence provided from the field of an unpackaged ar-1540ps, with batch number 15349365, revealed that the peek was broken.Therefore, arthrex was able to deduce the cause of the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the screw.

• Brand Name: PEEK 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: 21558812
• Report Number: 1220246-2025-00857
• Device Sequence Number: 13065481
• Product Code: HWC
• UDI-Device Identifier: 00888867018747
• UDI-Public: (01)00888867018747(11)241118(17)291031(10)15349365
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/12/2025

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 Model Number: PEEK TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1540PS
• Device Lot Number: 15349365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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