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

Model Number 72290001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case - (b)(4).

Event Description

It was reported that during a rotator cuff repair, the multifix wire of the suture loader broke while trying to load the suture legs through the snare loop.This left the sutures out of the device, with no ability to insert them.So, the surgeon passed the suture through the snare pulling the sutures by hand.The procedure was successfully completed without a significant delay.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

H10: h2, h3, h6.The reported device, used in treatment, was returned for evaluation.There was no 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 repeated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that mishandling the device can result in failure.Clinical evaluation was completed and concluded that per complaint details, 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.Based on the information provided, the breakage of the first suture passer did not occur inside of the patient.Additionally, it was reported, while the surgeon was using a second device, the same issue occurred.As a result, the surgeon used a change in surgical technique by using his hands to pull the sutures.According to the report, the procedure was successfully completed without a significant delay.Since no other complications were reported, no further clinical/medical assessment is warranted at time.Should any relevant medical information be provided, this compliant will be re-assessed.Visual evaluation shows a device returned deployed.The implant is not available.The device is intended for single use and functional test is not possible.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) incorrect suture loading.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: 10871970
• MDR Text Key: 217288983
• Report Number: 3006524618-2020-01011
• 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: foreign,health professional,o
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2050550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention