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

Catalog Number 72290001

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problems Bone Fracture(s) (1870); Perforation (2001); Muscle/Tendon Damage (4532)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a surgery, the multifix s-ultra black tip came loose, the anchor was in the bone, it did not rotate, and it was impossible to lower the plug that blocks the threads and allows the inserter to be removed.The anchor had to be pulled out turning the white handle in the opposite direction.The bone torn out with the anchor and damaged the tendon.The procedure was completed with 10-15minutes delay using a backup device available, but there was a void left in the patient.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found two multifix s-ultra laying on a surface.The black tip is detached for one of the devices, and the anchor is bent for the the other multifix.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 no 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 clinical review states that a photo provided shows the device was defective.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 information provided, a procedural variance was the likely cause of the reported adverse event.The patient¿s impact was the bone tear out with anchor, damaged tendon, additional bone hole, and the prolonged surgery.According to the report, no further complications were reported, and the patient is improving.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force on the device.No containment or corrective actions are recommended at this time.

• Brand Name: MULTIFIX S-ULTRA 5.5MM KNOTLESS 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: 18641421
• MDR Text Key: 334617140
• Report Number: 3006524618-2024-00052
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290001
• Device Lot Number: 2131407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2023
• 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
• Patient Outcome(s): Required Intervention; Other