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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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 (b)(6) 2025, a sales representative reported via email that an ar-2658tr knotless distal clavicle plate button tightrope encountered an issue during use.After drilling superior/inferior through the clavicle plate, clavicle, and coracoid using a 3.7 mm drill pin, an intraoperative x-ray revealed that the button had detached from the inserter and was located between the clavicle and coracoid.The surgeon retrieved the button within approximately two minutes.The surgeon attempted to rethread the button onto the inserter but was unable to engage the threads.Upon inspection, the threaded stylet did not protrude far enough to thread into the button properly.As a result, the procedure continued without significant delay, and the faulty implant was discarded and replaced with a new ar-2658tr device.The replacement implant was successfully deployed beneath the coracoid, achieving adequate reduction of the ac joint.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 07/30/2025: this occurred during a clavical orif with ac joint reduction on (b)(6) 2025.The bone quality was assessed as good.No photos or videos were taken of the event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-2658tr was received for investigation.Visual inspection of the button revealed damage around the threads and the edges of the hole.The inserter's threads were found to be stripped.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper surgical technique, misalignment insertion, and/or excessive force used for prying/leveraging of the device during insertion.

• 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: 22771672
• Report Number: 1220246-2025-03399
• Device Sequence Number: 9487950
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: (01)00888867271814(11)240606(17)290531(10)15270067
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 11/20/2025

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: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Device Catalogue Number: AR-2658TR
• Device Lot Number: 15270067
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown