MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 IFS; SCREW, FIXATION, BONE

Catalog Number	ASH4250-01
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a meniscectomy, the super turbovac tip was out of the device, it did not work when it was connected to the console.The procedure was completed with a delay greater than 30 minutes, and using a back-up device.No further complications were reported.
Event or Problem Description
It was reported that during a meniscectomy, the super turbovac tip would not work when it was connected to the console.The procedure was completed with a delay greater than 30 minutes, and using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection observed the returned instrument shows no manufacturing abnormalities.The electrode has been used.Bio debris is present.Product was out of the original packaging.No packaging returned.A functional evaluation revealed an e7 error was generated when the wand was connected after the controller was powered on.When used with a bypass box, coagulation and plasma were generated as intended.The resistance measured at 1.62 kilo ohms.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include: previous use, disconnecting the wand from the controller after power has been turned on.No containment or corrective actions are recommended at this time.

• Brand Name: SUPER TURBOVAC 90 IFS
• Common Device Name: SCREW, FIXATION, BONE
• 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: 18298606
• Report Number: 3006524618-2023-00502
• Device Sequence Number: 17901190
• Product Code: HWC
• UDI-Device Identifier: 00817470006506
• UDI-Public: 00817470006506
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083306
• 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,Followup
• Report Date (Section B): 05/19/2024

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: 07/04/2026
• Device Catalogue Number: ASH4250-01
• Device Lot Number: 2125118
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 05/14/2024
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 02/19/2024; 05/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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