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

Model Number FIBERTAK

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

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 the after the first anchor was seated, the shuttle sutures frayed and broke.The anchor remained in the patient; another anchor was placed on top of it.With the third ar-3638, the tip of the inserter broke off in bone; it was retrieved with a grasper.The case was completed with another ar-3638 used at the same site.No additional incisions were needed.Case was a labral repair.

Manufacturer Narrative

Complaint confirmed, the tip broke off.The device is missing approximately 1/2 in.Dimensional evaluation or relevant and available features revealed the device meets specifications.No other abnormalities observed.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: 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: 12075381
• MDR Text Key: 261474660
• Report Number: 1220246-2021-03318
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• Combination Product (y/n): N
• PMA/PMN Number: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 12830789
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1