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

Catalog Number	72290143
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, when the double knotless anchor was inserted into the bone hole, the anchor was broken, the distal end cap fell off from the handle and the deployment knob could not be twisted.All the pieces were removed.The procedure was completed using a back-up device.There was a delay of 2 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information: h6: medical device problem code.H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The suture loader was not returned.The distal body anchor is broken at the neck.The neck was returned on the device and the eyelet was not returned.The sleeve and proximal screw were returned on the device with no defect.The tip of the insertion device is bent.The black end cap has been detached from the driver.Bio debris is present.A functional evaluation showed the driver will rotate the tip but also will move up and down, loosely, in the insertion tube.The white knob will rotate but doesn't move the sleeve forward.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specifications found that tensile strength is specified and that a certificate of analysis is required with each shipment.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force, or misalignment of implant or inserter during and after insertion.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: DOUBLE FIX KNOTLESS PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20056302
• Report Number: 3006524618-2024-00338
• Device Sequence Number: 18222168
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 885556722497
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72290143
• Device Lot Number: 2139528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown