MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290123

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that, during an arthroscopic procedure with a q fix mini, upon winding the end of the anchor clockwise the middle spool came loose and separated from the anchor inserter.The anchor was not deployed and came loose from the patient.All suture material retrieved.The procedure was completed with a smith and nephew back up device by drilling a new bone hole.There was a delay of less than or equal to 30 min.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed the patient labels with the batch number of the complaint were returned for identification.The anchor was not returned.Part of the suture was returned wrapped around the cleat.An internal piece of the device, force limiting cage, was returned separated from the device which indicates the cleat has been removed from the device then reinserted without the internal piece.The insertion tube is bent.The device is covered in bio debris.A functional evaluation wasn't performed due to the anchor has already been deployed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the information provided, the clinical root cause of the reported events cannot be determined.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment can be rendered at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.The complaint was confirmed and the root cause was associated with unintended use of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: QFIX 1.8 MINI 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11041031
• MDR Text Key: 222619706
• Report Number: 3006524618-2020-01108
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556662618
• UDI-Public: 00885556662618
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 72290123
• Device Catalogue Number: 72290123
• Device Lot Number: 2045006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other