MAUDE Adverse Event Report: ARTHREX, INC. 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/01/2023, it was reported by a sales representative via sems that an ar-1322bcst single loaded suture tape anchor pulled out.This occurred during a procedure, they had to switch to a larger anchor to complete the case.There was no patient effect reported.There was no additional information provided, additional information has been requested.
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 causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17653318
• Report Number: 1220246-2023-07680
• Device Sequence Number: 20677637
• Product Code: MAI
• UDI-Device Identifier: 00888867392069
• UDI-Public: 00888867392069
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140855
• 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): 11/08/2024

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 Expiration Date: 12/31/2025
• Device Model Number: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-1322BCST
• Device Lot Number: 14916721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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