MAUDE Adverse Event Report: ARTHROCARE CORP. PERC DC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SDC01-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during use inside the patient, the tip of the wand broke.Surgeon confirmed there were no broken pieces left inside the patient.The procedure was completed with a s+n back up device.No significant delay and no patient injury or other complications were reported.
Additional Manufacturer Narrative
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 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states per the complaint details, the surgeon confirmed there were no broken pieces left inside of the patient.Based on the information provided, the procedure was completed with a s+n back up device with no significant delay.Since there were no patient injuries or other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.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.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: PERC DC
• 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: 12502254
• Report Number: 3006524618-2021-00927
• Device Sequence Number: 14296707
• Product Code: GEI
• UDI-Device Identifier: 00817470006162
• UDI-Public: 00817470006162
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 06/03/2022
• Device Model Number: SDC01-01
• Device Catalogue Number: SDC01-01
• Device Lot Number: 2035120
• 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: 08/27/2021
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 08/03/2022
• Date Device Manufactured: 06/03/2019
• 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