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

Model Number 25-2800

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/07/2018

Event Type  malfunction  

Event Description

It was reported that the suture did not come out from the anchor falling out.No patient injury reported.There was a time delay og over 30 minutes due to the issue.

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 q-fix all suture anchor 2.8mm show a deployed instrument and the implant is missing.Visual inspection shows no manufacturing abnormalities on the device.No drill/drill guide and no disposable kit were returned with the instrument.The device is a single used device and could not be functional tested.The complaint was not verified, as the device was used and deployed.The q fix suture anchor was pulled out of the hole.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: (1) bone quality.(2) drilled bone hole size.Poor bone quality or oversized drilled bone hole can result in damage to the device and device failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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
• MDR Report Key: 7469202
• MDR Text Key: 106909597
• Report Number: 3006524618-2018-00209
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470011029
• UDI-Public: (01)00817470011029(17)200131(10)1179865
• Combination Product (y/n): N
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 25-2800
• Device Catalogue Number: 25-2800
• Device Lot Number: 1179865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1