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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
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 07 november 2025, it was reported by a sales representative via email that an ar-2658tr, knotless dis clav plate button tightrop was reported to have failed during insertion.This occurred on (b)(6) 2025 during a clavicle orif.It was reported that the pec button slightly "off center" relative to inserter out of the packet.Hard to say if it was damaged or not screwed on correctly.Still attempted to use, though button came off inserter after passing through clavicle and before passing through corocoid.The case was completed successfully using a second implant.There was case involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.-complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging 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: 23631205
• Report Number: 1220246-2025-05161
• Device Sequence Number: 13340906
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: (01)00888867271814(11)250520(17)300430(10)15439069
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/06/2026

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: 15439069
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown