MAUDE Adverse Event Report: ARTHREX, INC. LARGE PEC BUTTON KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	LARGE PEC BUTTON KIT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/18/2024, it was reported by a sales representative via sems-06542677 that the button inserters from an ar-2269 pec repair implant delivery system were bent to the point that the button struggled to unscrew from the stylet.The case was completed by opening individual buttons.The patient was not affected.This was discovered during a pec repair procedure.Additional information received on 4/25/2024: the procedure occurred on (b)(6) 2024.The case was not delayed.Additional anesthesia was unnecessary, and the patient suffered no negative effects.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: LARGE PEC BUTTON KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19300417
• Report Number: 1220246-2024-03201
• Device Sequence Number: 6015277
• Product Code: MBI
• UDI-Device Identifier: 00888867026582
• UDI-Public: 00888867026582
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• 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): 06/12/2025

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: LARGE PEC BUTTON KIT
• Device Catalogue Number: AR-2269
• Device Lot Number: 15193306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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