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

Model Number KNOTLESS HIP FIBERTAK

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, it was reported by a sales representative via sems that an ar-3638h knotless hip fibertak anchor came out of the package with no purple line indicating where to fold the suture over for shuttling.Without the purple line it was difficult for the surgeon to be sure and confident in shuttling, which resulted in the repair stitch sliding out of the loop while shuttling and was left with just the #2 repair stitch.To complete the case the surgeon then had to dunk this stitch into a pushlock anchor.

• 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: 12954041
• MDR Text Key: 281902727
• Report Number: 1220246-2021-04068
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638H
• Device Lot Number: 13874343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2021
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other