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

Model Number	2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that (2) ar-1322bcst 2.4 single loaded suturetape s-tak assy anchor broke off at the tip during insertion when drilling into hard bone.The case was completed by putting in 3.0 anchors for drilling instead with no issues.This was discovered during an unspecified procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image from the field, it was noted that the anchor broke during insertion.Consequently, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: NON-DEGRADABLE FIXATION 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: 18769253
• Report Number: 1220246-2024-01094
• Device Sequence Number: 20782324
• Product Code: MAI
• UDI-Device Identifier: 00888867392069
• UDI-Public: 00888867392069
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/05/2025

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: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-1322BCST
• Device Lot Number: 15090470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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