MAUDE Adverse Event Report: ARTHREX, INC. TENSIONLOC COLLAR AND PLUG IMPLANT 10MM; BONE FIXATION SCREW/PLATE

Model Number	TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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 10-feb-2026, an arthrex subsidiary employee reported via email that an ar-5210 tensionloc collar and plug implant (10 mm) experienced an issue during a procedure performed on (b)(6) 2026.A portion of the collar broke while it was being hammered in.The broken piece was removed using an elevator, and a replacement ar-5210 implant was successfully inserted.The procedure was completed without significant delay.No additional anesthesia was required, and no patient harm was reported.

• Brand Name: TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
• 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: 24482219
• Report Number: 1220246-2026-01100
• Device Sequence Number: 21415495
• Product Code: HWC
• UDI-Device Identifier: 00888867265820
• UDI-Public: (01)00888867265820(11)250722(17)300630(10)15470601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183628
• 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): 06/08/2026

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: TENSIONLOC COLLAR AND PLUG IMPLANT 10MM
• Device Catalogue Number: AR-5210
• Device Lot Number: 15470601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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