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 Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

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 that during a procedure, when a needle from a dx fibertak was found not attached to the suture.The product was already implanted into the patient and could not be removed and a free needle was opened to complete the procedure.Additional information 12/28/2020: it was reported that during a deltoid ligament repair procedure, when a needle from a dx fibertak was suture was not loaded onto the needle when the silicone cover came off.The product was already implanted into the patient and could not be removed.The case was completed with free needle being used for the suture limb.

• 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: 11120142
• MDR Text Key: 225257319
• Report Number: 1220246-2021-02455
• 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: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: 11896126
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other