MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, ST & NDLS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number DX FIBERTAK SUTURE ANCHOR, ST & NDLS

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2020

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.

Event Description

It was reported during a peroneal tendon repair the surgeon drilled using a 1.6 drill within the kit.After implanting the ar-8990st dx fibertak suture anchor, the anchor pulled right out of the bone.The surgeon drilled a new tunnel and attempted to implant a second ar-8990st from the same lot.However, the same exact issue occurred with the second anchor.No piece broke off from either device.The bone quality was hard.There was not an arthrex sales representative present during the procedure, and it is unknown how the case was completed after the product malfunctions occurred.The rep stated they are following up with the surgeon to obtain the details of how the case was completed.Additional information received on 04/01/2020: the rep reported the surgeon was able to complete the procedure by doing a different repair using only suture.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• 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: 9985587
• MDR Text Key: 190501259
• Report Number: 1220246-2020-01808
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10888867301051
• UDI-Public: 10888867301051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• Device Catalogue Number: AR-8990ST
• Device Lot Number: 10539970
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other