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 Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.One unpackaged ar-8990st serial/batch number (b)(6) was received for investigation.Visual evaluation revealed that the fibertak inserter shaft's tip was significantly bent; no other issues were observed in the device.This event is most likely caused by prying/levering the device against hard bone or other instrumentation during use.
Event or Problem Description
On 11/22/2022, it was reported by an arthrex employee via email that an ar-8990st fibertak dx suture anchor inserter did not pass through when inserting and the inserter shaft bent after it was tapped in.Surgeon used a new product and case was completed.This was discovered during a procedure on (b)(6) 2022.Additional information received on 11/28/2022: this was discovered during a lateral ligament repair of the ankle joint and completed using an ar-8990st fibertak dx suture.The shaft bent but did not break.

• 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: 19579244
• Report Number: 1220246-2024-06305
• Device Sequence Number: 8409877
• Product Code: MBI
• UDI-Device Identifier: 10888867301051
• UDI-Public: 10888867301051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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 Model Number: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• Device Catalogue Number: AR-8990ST
• Device Lot Number: 14955884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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