MAUDE Adverse Event Report: ARTHROCARE CORPORATION MICROBLATOR 30 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC4050-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ankle arthroscopy, the radiofrequency of the microblator was broken, the specialist tried to remove it with a hook probe but it was not possible, then, the specialist tried to remove the piece increasing the pressure on the pump, but it was not possible to know its exact location and made the decision to open to explore.X rays were taken and the piece could be seen embedded in the insert of the prosthesis so the insert was removed.The procedure was completed with a back up device with a three hour delay.The patient's health is still to be confirmed.
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 no 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 the provided intraoperative photo confirms the reported break of the tip of the radiofrequency.Based on the limited information provided, the clinical root cause of the reported breakage of the microblator could not be definitively concluded, the root cause of the hook probe was the attempted removal of microblator fragment.The hook probe is an external communicating device composed of surgical stainless steel 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 broken piece of the hook probe is in an unknown location, it is possible that it is retained within the patient, and the potential for micromotion and/or migration cannot be ruled out.Additionally, the open procedure and prolonged anesthesia time increases the risk for post-surgical complications and possibly recovery time for the patient.Factors that could have contributed to the reported event include hitting the device tip against a hard surface or using the device as a lever to enlarge surgical site.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: MICROBLATOR 30 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: 17908087
• Report Number: 3006524618-2023-00385
• Device Sequence Number: 7561136
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 00817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 02/16/2026
• Device Catalogue Number: AC4050-01
• Device Lot Number: 2113836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/27/2023
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male