MAUDE Adverse Event Report: ARTHROCARE CORPORATION TRISTAR 50 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ASC4630-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had primary arthroscopy surgery using a tristar 50 icw in september 2023.The patient was re-examined, and an x-ray showed fragments of metal inside the patient, the wand tip fell off when used and was not detected by the surgeon.The fragments of metal cannot be removed from the patient's body.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: 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.The instructions for use were 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 that as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors identified which would have contributed to the reported event.The tristar 50 wand is an external communicating device that is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long-term implantation data is not available.Since the fragments remain inside of the patient, the potential for micromotion/migration, local tissue inflammation and/or pain cannot be ruled out.No further clinical assessment is warranted at this time.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.

• Brand Name: TRISTAR 50 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 18358502
• Report Number: 3006524618-2023-00510
• Device Sequence Number: 20860393
• Product Code: GEI
• UDI-Device Identifier: 00817470001921
• UDI-Public: 00817470001921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 09/07/2024
• Device Catalogue Number: ASC4630-01
• Device Lot Number: 2077979
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/19/2024
• Date Device Manufactured: 09/07/2021
• 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 Sex: Unknown