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

Catalog Number	72290143
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl procedure, the double fix knotless pk presented an issue.Upon insertion into the joint, when the suture was being passed through the anchor, the device fractured; all broken pieces were retrieved from the patient.Surgery continued without any delay; however it is unknown how it was completed.No further complications were reported.No further details available.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The distal anchor, collar, and proximal anchor are off the device.The distal anchor is broken at the eyelet.The insertion device has no visual defect.Bio debris is present.A functional evaluation revealed the knob is fixed and the anchors have already been deployed.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 the tensile strength for the material is specified and 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 reported event include: (1) excessive force, (2) misalignment of implant or inserter during and after insertion.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 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: 18378051
• Report Number: 3006524618-2023-00513
• Device Sequence Number: 7600926
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 Expiration Date: 07/26/2025
• Device Catalogue Number: 72290143
• Device Lot Number: 2097942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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