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 Slipped (1584)

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

Event Date 01/15/2020

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff repair, while using the q-fix all suture anchor, the anchor came out.An additional bone hole was required.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The returned instrument, used in treatment, was returned for evaluation.There was a 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.However, there is a piece of suture anchor left in the device.There are no visible manufacturing abnormalities found on the device.The limited functional evaluation showed that the dial isn´t fixed and can be turned.The device is a single use device and could not be fully functional tested.The complaint was not verified.From the information provided, the anchor did not get secured inside the bone hole.An exact root cause cannot be determined with confidence.

• 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: 9694654
• MDR Text Key: 178647793
• Report Number: 3006524618-2020-00045
• Device Sequence Number: 1
• Product Code: MBI
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 25-2800
• Device Catalogue Number: 25-2800
• Device Lot Number: 2029994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1