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	Insufficient Information (4580)
Date of Event	06/12/2024
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 06/13/2024, it was reported by a sales representative via sems-(b)(4) that an ar-2658tr suture anchor and an ar-2372blo knotless ac tightrope® open repair implants buttons popped off of the inserter and they weren't able to screw then back on.This occurred during an ac joint repair on (b)(6) 2024.
Event or Problem Description
Additional information was provided on 06/18/2024 when the sales representative stated that the buttons had come off both devices prematurely.They were able to retrieve them.They used the drill that came in the kit to prepare both bone tunnels.The patient had good bone quality.They used a cerclage fiber tape suture to proceed.
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.Per surgical technique lt1-02553-e 3-insert the coracoid button into the clavicle tunnel.Light taps on the inserter handle can aid in advancing the button through the tunnels.4-insert the coracoid button through the clavicle and the coracoid tunnel.Fluoroscopy may be used to confirm proper button alignment and that it extends below the inferior cortex of the coracoid.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or 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: 19689787
• Report Number: 1220246-2024-06620
• Device Sequence Number: 15484479
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: 00888867271814
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 15158627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 03/17/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/18/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown