MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, ST & NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, ST & NDLS
Medical Device Problem Codes	Material Frayed (1262); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-8990st fibertak dx sutures would not side after implantation.When the suture finally freed up, it was cut in half and frayed.The inserter was not broken in the fork tip area and the bone was not too hard when drilling.This was discovered during a procedure.Additional information received on 6/5/2024: this was discovered during a brostrom repair procedure on (b)(6) 2024.The case was completed using another ar-8990st fibertak dx.The sheath was not retrieved.The case was delayed five minutes without additional anesthesia.
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.The complaint allegation is confirmed.Based on the image provided from the field, it was evident that the sutures were torn.Consequently, arthrex was able to conclude a most likely cause.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• 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: 19607132
• Report Number: 1220246-2024-06415
• Device Sequence Number: 12783477
• Product Code: MBI
• UDI-Device Identifier: 10888867301051
• UDI-Public: 10888867301051
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• 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
• 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: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• Device Catalogue Number: AR-8990ST
• Device Lot Number: 15178641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown