MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 6/16/2022, it was reported by a sales representative via phone that an ar-3603-2 fibertak was attempted to be implanted three times and it would not seat.The first time, when surgeon pulled the sutures to cinch down, the anchor pulled out.After reloading the anchor again, the surgeon attempted to implant it one more time, same thing happened, the anchor pulled out.The third time, a new bone socket was created and the anchor was implanted, this time too, the anchor pulled out.Surgeon completed case using a device from another manufacturer along with a knotless fibertak.This was discovered during a bankart repair (b)(6) 2022.

• Brand Name: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• 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: 19444341
• Report Number: 1220246-2024-04648
• Device Sequence Number: 8545665
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2024

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: 04/30/2026
• Device Model Number: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Device Catalogue Number: AR-3603-2
• Device Lot Number: 13334564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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