MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS SUTURE PASSER

Model Number	224035
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, 4.0mm dia nail 4.0mm x 35cm didn't work during surgery.It was a delay during surgery greater than 30 minutes.The procedure finished with the same device.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Event or Problem Description
It was reported that, the firstpass suture passer didn't work during surgery.It was a delay during surgery greather than 30 minutes.The procedure finished with the same device.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Report was inadvertently submitted under manufacturer number ¿1020279¿ but the correct manufacturer number is ¿3006524618.¿.
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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.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: FIRSTPASS SUTURE PASSER
• Common Device Name: PASSER
• 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: 10457259
• Report Number: 1020279-2020-04229
• Device Sequence Number: 4016182
• Product Code: HWQ
• UDI-Device Identifier: 03596010105059
• UDI-Public: 03596010105059
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/10/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 224035
• Device Catalogue Number: 22-4035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/29/2021; 11/17/2021; 11/17/2021; 01/09/2023
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 07/31/2021; 11/17/2021; 11/17/2021; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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