MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number FIBERTAK

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, it was reported by a sales representative via e-mail that while the surgeon was performing a labral repair on (b)(6) 2021, quantity 6 of an ar-3638, lot: 13255279, pull out at various points during the implanting/tension process.The surgeon also used the reusable curved guide with the 1.8mm drill, ar-3600nd-2, lot: 12691838, cycling multiple times as recommended and pulling back to set the anchor.The case was completed by drilling new spots and placing new ar-3638 from a different lot.

Manufacturer Narrative

Complaint confirmed.Three unpackaged ar-3638 knotless fibertak¿ with #2 suture were received for investigation.Visual inspection identified that only two fibertak were returned with suture components, no damage observed.No breakage was observed across any of the returned inserters.Third suture had breakage at the nod and fray ends.The cause remains undetermined.However, the most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: FIBERTAK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12658799
• MDR Text Key: 277345402
• Report Number: 1220246-2021-03807
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 13255279
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other