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

Model Number FIBERTAK

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 02/13/2020

Event Type  Injury  

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.

Event Description

It was reported during a bankart labral repair procedure, the ar-3638 fibertak (lot: 10558056) pulled out of the bone and was not implanted.A second ar-3638 from the same lot was implanted successfully, shuttled through the locking mechanism successfully, but would not fully tension.The surgeon pulled the free end of the repair suture as hard as they could, and even used a hemostat around the suture to get all the slack out, but it was still loose.The surgeon pulled hard on the repair suture and it broke, but it was still not tensioning the labrum and the repair suture around the labrum was loose.The second implant remained and implanted.A third ar-3638 from the same lot was brought in and implanted successfully.The bone was prepped by using the curved drill guide with 1.8mm flexible drill.The bone quality was hard.

• 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: 9808268
• MDR Text Key: 190939207
• Report Number: 1220246-2020-01754
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• 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: 10558056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other