MAUDE Adverse Event Report: ARTHROCARE CORP. DOUBLE FIX KNOTLESS PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72290143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the wire of the double fix knotless threader was broken, the devices could not be used.The device broke inside the patient and all the pieces were removed.It is unknown how were they removed.The procedure was completed with a s+n back up device.No delay and no other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the instrument shows no manufacturing abnormalities.The snare wire and cross bar were returned with device damaged.A basic functional evaluation shows the deployment knob can be rotated and stop clockwise.The suture loading portion of the device was returned damaged and cannot be functionally tested.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: DOUBLE FIX KNOTLESS PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11936054
• Report Number: 3006524618-2021-00691
• Device Sequence Number: 1297095
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 00885556722497
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 12/04/2022
• Device Model Number: 72290143
• Device Catalogue Number: 72290143
• Device Lot Number: 2045342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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: Other; Required Intervention