MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED FW CL; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK DOUBLE LOADED FW CL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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.- it was reported that the suture deforms and detaches from the inserter.- visual evaluation identified that the sutures appeared to be deformed and detached from the inserter.However, without the return of product, further investigation cannot be performed.- the root cause of the reported failure mode is undetermined.- the reported event is confirmed based on the investigation of the returned pictures.
Event or Problem Description
It was reported that during a shoulder instability repair procedure, when the surgeon was entering the fibertak through the instruments, it enters with difficulty, as the input progresses, it becomes deformed and causes detachment of the suture.This issue occurred with 3 implants.The case was completed by using a new device.

• Brand Name: FIBERTAK DOUBLE LOADED FW CL
• 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: 19558761
• Report Number: 1220246-2024-05931
• Device Sequence Number: 11965024
• Product Code: MBI
• UDI-Device Identifier: 00888867206960
• UDI-Public: 00888867206960
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: FIBERTAK DOUBLE LOADED FW CL
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 11798761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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