MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM 2 KNOTLESS IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number OM-1502

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

It was reported that during an open rotator cuff repair procedure, after loading the magnum implant into the device, the surgeon removed the suture slack outside of the joint using the ratchet, pushed the device into the pilot hole, then removed further slack whilst the anchor was inserted into the pilot hole.At this point, the wire mechanism snapped and the ratchet system of the magnum would not work.The snare wire then poked out of the device near the ratchet knob.The surgeon removed the device and freed both suture ends from the device.The procedure was successfully completed without significant delay using a suture from a metal twinfix ultra anchor which was inserted into the patient as the medial row anchor and the suture limbs of which were then loaded into the magnum 2 anchor in the same bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.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 review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.A review of the instructions for use found that mishandling the device can result in failure.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle with the bone hole.No containment or corrective actions are recommended at this time.There were no indications that would suggest that 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.

• Brand Name: MAGNUM 2 KNOTLESS IMPLANT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10727397
• MDR Text Key: 212755825
• Report Number: 3006524618-2020-00916
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (y/n): N
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 06/20/2022
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2035865
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention