MAUDE Adverse Event Report: ARTHROCARE CORP. 2.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 25-2800

Device Problems Detachment of Device or Device Component (2907); Activation Problem (4042)

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

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

The returned instrument, intended for use in treatment, was returned for evaluation.There was no relationship found between the device and the reported incident.Visual inspection of the returned 2.8mm q-fix all suture anchor shows a deployed instrument.Remaining sutures were visible outside the handle.The implant is detached and a remaining part of the implant is inside the shaft at distal end.There are no visible manufacturing abnormalities found on the device.Functional evaluation could not be performed.The device is a single used device and could not be functional tested.The complaint was not verified.From the information provided, the anchor did not fully deploy.The q fix anchor was pulled out of the bone hole and a remaining part of the implant is inside the shaft at distal end.An exact root cause cannot be determined with confidence; however, factor unrelated to the manufacture or design of the device that could have contributed to the reported event include: bone quality.Drilled bone hole size; poor bone quality or oversized drilled bone hole can result in damage to the device and device failure.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during the surgery, after the site was prepped, the knob was rotating, the anchor did not deploy in the site.5 minutes delay was the procedure.No patient injury was reported.A backup device was used.Results of investigation have concluded that the implant is detached and a remaining part of the implant is inside the shaft at distal end.

• Brand Name: 2.8MM Q-FIX ALL SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8550680
• MDR Text Key: 143380359
• Report Number: 3006524618-2019-00200
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 25-2800
• Device Lot Number: 2013531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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