MAUDE Adverse Event Report: ARTHROCARE CORP. TURBOVAC 90 XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC1336-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2021
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 tip central part of the turbovac wand disconnected when using.The metal part could not be removed from patient hip joint.The procedure was successfully completed without delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information: h6: health effect - impact code.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 found no similar reported events.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 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 clinical review states this case reports a breakage of the turbovac wand tip which was unable to be retrieved from the patient.One undated intraoperative photo was provided for review but does not assist in the root cause of the reported event.Impact with other instruments or prolonged use could result in this breakage but neither were reported.Conclusion: based on the limited information provided the root cause of the reported wand tip breakage could not be confirmed with the information provided.Long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.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.

• Brand Name: TURBOVAC 90 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12734170
• Report Number: 3006524618-2021-00994
• Device Sequence Number: 16520900
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: 00817470006520
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 10/28/2023
• Device Model Number: ASC1336-01
• Device Catalogue Number: ASC1336-01
• Device Lot Number: 2063311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/26/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male