MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS; NON-DEGRADABLE FIXATION FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after pulling the inserter of the ar-8990 fibertak suture anchor and completing the detention, the surgeon removed it from the guide and checked the placement of the anchor by pulling it and the anchor came off.Surgeon installed a new product in a different place and surgery was completed successfully with no adverse effect on the patient.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 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 confirmed.Visual inspection identified that the suture construct was still present, but damaged.The cause is undetermined, however the most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• 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: 19250261
• Report Number: 1220246-2024-02836
• Device Sequence Number: 7309935
• Product Code: MBI
• UDI-Device Identifier: 00888867265004
• UDI-Public: 00888867265004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 08/31/2025
• Device Model Number: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• Device Catalogue Number: AR-8990
• Device Lot Number: 11758013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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