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 07/08/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder arthroscopy, the suture passing wire of the multifix anchor was broken.The procedure was successfully completed without significant delay using the same device.No patient injury or 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

H3, h6 h10: 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 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 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: -failure to distribute proper tension through both suture ends may result in inadequate suture lock and potential failure.-implantation of this device requires an appropriate level of surgical skill and experience.Surgeons who plan to use this device should carefully review the instructions for use prior to clinical use.-do not over tension the sutures as breakage or tissue pull through may occur.Additionally, over tensioning the suture may result in incomplete insertion or implant pull out.Visual evaluation shows the device returned non-deployed.The ribbon is broken and attached to the implant.The device is intended for single use and can not be tested.Factors that could have contributed to the reported event include: (1) excessive force (2) 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: 10428458
• MDR Text Key: 203637451
• Report Number: 3006524618-2020-00659
• 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: 10/14/2020

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: 08/28/2022
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2038708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention