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

Model Number KNOTLESS HIP FIBERTAK

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 04/10/2021

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

It was reported that during a hip arthroscopy the knotless anchor was placed and while tightening the suture it ruptured and the implant remained in the patient.The surgeon reported that there was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint not confirmed.Visual inspection did not identified any damaged or abnormalities to the returned sheaths.The cause could not be determined as the anchor remains in the patient as stated in the event description.

• Brand Name: KNOTLESS HIP FIBERTAK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872311
• MDR Text Key: 255339072
• Report Number: 1220246-2021-03150
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867295575
• UDI-Public: 00888867295575
• Combination Product (y/n): N
• PMA/PMN Number: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638H-1
• Device Lot Number: 11265251
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2021
• Patient Sequence Number: 1