MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290001

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

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  Injury  

Event Description

It was reported that while the anchor was applied to the patient in accordance with the use, it was broken and dislodged.The malfunction was solved with a delay shorter than 30 minutes and no patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found statements regarding device breakage.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.A review of the product/print specifications found no discrepancies.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to:(1) tissue thickness.(2) misalignment of inserter handle.(3) excessive force.(4) over tensioning the suture.No containment or corrective actions are recommended at this time.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not returned in any original packaging.The anchor and sleeve were not returned.The screw is deformed but still on the device.The anchor insertion rod is bent.The suture threader is bowed from use.A functional evaluation was performed on the returned device and found the screw deployment knob is locked.The end cap rotates the anchor rod forward and back.A material assessment could not be performed due to the distal anchor and sleeve not being returned for evaluations.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.The instructions for use were 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.A review of the material specifications found that tensile strength specifications are established.Also, certificate of analysis is required with each shipment.A clinical review states that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided the clinical root cause of the reported breakage could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device instruction for use does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.The multifix anchors are implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further risk to the patient is anticipated as a result of the additional bone hole.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include tissue thickness, misalignment of inserter handle, excessive force or over tensioning the suture.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during an unspecified procedure, while the multifix anchor was applied to the patient in accordance with the use, it was broken and dislodged.The procedure was completed with a delay shorter than 30 minutes using a back-up device.No further complications were reported.

• Brand Name: MULTIFIX S-ULTRA 5.5MM KNOTLESS 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: 10653314
• MDR Text Key: 210569688
• Report Number: 3006524618-2020-00859
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 00885556614204
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K153669
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2047424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 11/03/2020; 03/20/2024
• Supplement Dates FDA Received: 11/12/2020; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• 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; Other