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
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.
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 reported event is confirmed based on the investigation of the returned pictures.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 most likely cause for the reported failure can be attributed to improper bone prep, misaligned insertion, prying/leveraging the device during insertion.According to dfu-0054-9.G.Precautions.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.According to surgical technique.Insert the anchor through the spear and into bone by gentle impaction until the inserter handle is flush with the back of the spear.Note: if insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.Avoid excessive impaction as this could lead to inserter damage and/or breakage.

• 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: 19558720
• Report Number: 1220246-2024-05929
• Device Sequence Number: 11974592
• 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: 06/30/2025
• Device Model Number: FIBERTAK DOUBLE LOADED FW CL
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 11331699
• 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: 07/20/2020
• 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