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

Model Number FIBERTAK

Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

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 that during a (b)(6) 2020, labral repair, procedure two ar-3638, knotless fibertak anchors (lot 11339110) did not hold in the patient bone.Both anchors pulled out.A curved guide and flexible drill were used to prep the bone for insertion.They bottomed out the drill and cycled it as the technique indicated to clear bone from the tunnel.The anchor was inserted and the suture was passed.When they went to tension it down the anchor pulled out.They drilled a new hole and used another anchor and did the same technique but the anchor pulled out again.It was a small tear and once the two anchors pulled out the surgeon chose to just debride it and closed with no repair.Patient bone quality was reported to be hard.Both anchors that had issue were discarded at time of procedure.

• 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: 10843472
• MDR Text Key: 216359204
• Report Number: 1220246-2020-02344
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11339110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other