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

Model Number KNOTLESS HIP FIBERTAK

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

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

It was reported on (b)(6) 2022 by a sales representative via phone that an ar-3638h fibertak implant would not seat.This was discovered during a case with no patient harm.This was discovered during a case broke within the joint space.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15395137
• MDR Text Key: 305612585
• Report Number: 1220246-2022-05466
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867295568
• UDI-Public: 00888867295568
• 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
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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
• Device Lot Number: 14269910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2022
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1