MAUDE Adverse Event Report: ARTHROCARE CORP. 1.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 25-1800

Device Problems Device Dislodged or Dislocated (2923); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported that, during an abr procedure, the dial of the q-fix was turned to stiff while the anchor was deployed.The anchor failed to be deployed and it came off from the shaft and bone hole.The anchor was removed from the patient.The procedure was completed without delay using a back-up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed the device was not returned in original packaging.The anchor and sutures were not returned.No other visible deficiencies were found.A functional evaluation showed the deployment knob rotates forward and backward which moves the cleat up and down in the handle.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 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.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) incorrect bone hole preparation.(2) improper depth insertion.Or, (3) bone hole not clear of material.No containment or corrective actions are recommended at this time.

• Brand Name: 1.8MM 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12782663
• MDR Text Key: 280574644
• Report Number: 3006524618-2021-01009
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724606
• UDI-Public: 885556724606
• 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
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Catalogue Number: 25-1800
• Device Lot Number: 2071677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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): Required Intervention