MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP; BONE FIXATION PLATE

Model Number	KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/10/2025, a sales representative reported via email that an ar-2658tr knotless distal clavicle plate button tightrope experienced an issue during insertion.Specifically, the button detached from the inserter and flipped before passing through the coracoid.The button was successfully explanted without complications; however, an additional implant had to be opened to complete the procedure.This occurred during a distal clavicle fracture with cc ligament repair performed on (b)(6) 2025, with no reported patient harm.Additional information was received on 10/15/2025: an ar-2658tr knotless distal clavicle plate button tightrope was utilized to complete the procedure.The surgery experienced a 5-minute delay while the surgeon attempted to preserve and reload the implant onto the inserter.After determining that the tightrope could not be salvaged, it was removed and replaced with a new implant of the same part number.No additional anesthesia was administered to the patient during this delay.The instrument used to prepare the bone tunnel was the ar-2272 (3.7 mm spade-tip drill pin).The patient's bone quality was assessed as good.No adverse effects were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The failure appears to be due to user error, including improper use of the surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of the failure was received.

• Brand Name: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Common Device Name: BONE FIXATION 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: 23360219
• Report Number: 1220246-2025-04764
• Device Sequence Number: 21104961
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: (01)00888867271814(11)250124(17)291231(10)15377970
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• 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): 02/25/2026

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: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Device Catalogue Number: AR-2658TR
• Device Lot Number: 15377970
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown