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

Catalog Number 25-1800

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a procedure, when the dial was turned, the suture of the q-fix was frayed and broke.The procedure was completed using a smith and nephew back up device.There was a 5-min delay and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not returned in any original packaging.The anchor was not returned.The insertion tube is fully extended and bent.The bulk of the sutures are on the cleat, but the cleat has been removed from the device.One suture has been cut and the other has rubbed against a sharp edge to the point of breaking.Both cuts are from just below the anchor.A functional evaluation could not be performed due to the anchor has been deployed and the condition the insertion device was returned in.Based on the condition of the product material found during visual inspection, additional material testing is not required.These findings are related to the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.A review of the material specifications found that the sutures must comply with a break strength of 8.4 - 10.4 lbs.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force, or suture contact with sharp objects.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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18424805
• MDR Text Key: 331923052
• Report Number: 3006524618-2024-00001
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-1800
• Device Lot Number: 2131270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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