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

Model Number FIBERTAK

Device Problems Break (1069); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

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 6/10/2022, it was reported by a sales representative via email that an ar-3638 knotless fibertak inserter tip broke off in glenoid while inserting the anchor and passing the suture.Everything was removed from the patient and a second ar-3638 knotless fibertak was opened.This time, the anchor would not tighten down and was also removed.This was discovered during a shoulder arthroscopy labral repair on (b)(6) 2022.

• 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: 14829107
• MDR Text Key: 303244679
• Report Number: 1220246-2022-05144
• 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: K181769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 14922662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2022
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1