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

Model Number FIBERTAK

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/22/2021

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 bankart repair the anchor was implanted but the blue wire could not be tightened.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.On 22-sep-2021: update: further information were provided that the blue wire could not be pulled and tightened.Therefore the wire had to be cut off and the anchor remained in the patient.

Manufacturer Narrative

Complaint confirmed.Seven unpackaged ar-3638-1 assemblies were received for investigation.Visual inspection identified that only two out of seven fibertak inserters were returned with white/blue suturetape components.Breakage was present at the ends of both returned suturetape constructs.Two out of seven fibertak inserters were severely bent at the distal tip.No breakage was observed across any of the returned inserters.The cause remains undetermined.No information was provided in terms of the method used to prepare the bone, as well as the bone quality encountered.Based on the bent condition of two of the returned inserters, a probable cause can be attributed to improper bone preparation and/or user-applied mechanical forces during insertion.

• 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: 12615636
• MDR Text Key: 277913303
• Report Number: 1220246-2021-03780
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867290945
• UDI-Public: 00888867290945
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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-3638-1
• Device Lot Number: 13389274
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2021
• Patient Sequence Number: 1