MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, 2.5 X 6MM, PEEK; BONE FIXATION SCREW/PLATE

Model Number	TENODESIS SCREW, 2.5 X 6MM, PEEK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
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
It was reported that during a sl-band reconstruction the tip of the screw broke when it was inserted.The same screw was used to finish the surgery successfully and the broken piece remained inside the patient.The surgery was finished successfully and it was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence, via an x-ray, provided from the field of an unpackaged ar-1525ps, with batch number 11474059, revealed a damaged screw.Therefore, arthrex was able to deduce a most likely cause.The most likely cause can be misuse due to misaligned insertion or prying/leveraging the screw during insertion.

• Brand Name: TENODESIS SCREW, 2.5 X 6MM, PEEK
• 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: 21745557
• Report Number: 1220246-2025-01162
• Device Sequence Number: 15837073
• Product Code: HWC
• UDI-Device Identifier: 00888867301801
• UDI-Public: (01)00888867301801(11)200810(17)250731(10)11474059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183395
• 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): 07/17/2025

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: 07/31/2025
• Device Model Number: TENODESIS SCREW, 2.5 X 6MM, PEEK
• Device Catalogue Number: AR-1525PS
• Device Lot Number: 11474059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown