MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

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

On (b)(6) 2021 it was reported by a sales representative via email that an ar-3651tt, fibertak dr lbrltape, was being used in an rcr procedure.During insertion, the fork tip of the anchor broke off within the patient's joint and was unable to be retrieved.The case was completed with a second anchor with the same pn without further incident.

Manufacturer Narrative

Complaint confirmed.Visual evaluation confirms that one of the fork tips, at the distal end has broken off.Broken piece and suture were not returned for evaluation.Device functioning was not performed due to the broken condition of the device.The cause of this event is undetermined; however, a most likely cause of this event is the application of prying/leveraging forces to the device during use.

• Brand Name: FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK
• 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: 13087737
• MDR Text Key: 285041508
• Report Number: 1220246-2021-04181
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867225053
• UDI-Public: 00888867225053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK
• Device Catalogue Number: AR-3651TT
• Device Lot Number: 14357495
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1