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

Model Number 72290001

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

The sample is under evaluation by the manufacturing site.

Event Description

It was reported that the 5.5 mm knotless anchor of the multifix s-ultra broke.The incident occurred before the procedure; therefore, there was no patient involvement.Preliminary results of investigation have concluded that this device was being used inside the patient which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h2, h3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive force can result in device damage.Visual inspection shows a broken-off anchor at the tip.The device was returned with three(3) detached /separated parts of the anchor.No manufacturing abnormalities visually observed.The returned instrument is a single use device an could not be functional tested.An attempt was made to test the basic functions.The dial can be rotated clockwise in both directions.The end cap including the rod at distal end can also be continuously rotated in both directions.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) poor bone quality (2) misalignment of inserter handle.(3) bone hole size.(4) over tensioning the suture.(5) excessive probing.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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
• MDR Report Key: 10603563
• MDR Text Key: 209133013
• Report Number: 3006524618-2020-00833
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 00885556614204
• Combination Product (y/n): N
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2001352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1