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

Model Number	OM-1502
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery, the suture lost its tension on the cuff after the point locking down with the anchor.As per complainant report, it was like the internal locking system on the anchor which caused that the anchor did not lock down sufficiently.Surgery was completed using a smith and nephew back-up device with no significant delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device intended to be 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: the implant system requires tension to be distributed through both suture legs to achieve suture lock deployment.The use of a locking suture stitch (i.E.Modified mason-allen) may cause tensioning to be more difficult due to the inability of the suture legs to move freely through the tendon.Tensioning the suture knobs prior to snaring the suture may compromise the suture snare.Activating the ratchet release will alleviate tension on the suture snare.Preoperative and operative procedures, including proper patient selection, knowledge of surgical techniques, and proper implant selection are important considerations when using this anchor system.Factors that could have contributed to the reported event include: (1) improper suture loading, (2) excessive tensioning.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
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10371503
• Report Number: 3006524618-2020-00594
• Device Sequence Number: 3092360
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K042914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2022
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2045313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention