MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290129

Device Problems Break (1069); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that during a shoulder stabilization procedure, the doctor prepared the mini suture passer left with an a suture, pass the firstpass mini through an s+n orange cannula.On first attempt the doctor grasp the labral tissue that he wanted and proceeded to pull the trigger on the firstpass.The needle and suture did not pass through the suture grasper.On releasing of the trigger the end of the first pass mini top jaw detached from the main body.The doctor removed the device and the fragment remained in the patient.The doctor then removed the material from the shoulder using a grasper, all material was removed and accounted for.The procedure was successfully completed with non-significant delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

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 concluded this was a repeat issue.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 one undated photo of the device was provided for review and confirm the reported.Per the customer feedback form, ¿all material was removed and accounted for.¿ the procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A review of the customer provided image shows a detached upper jaw.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.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.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection found the the upper jaw detached.The upper jaw was not returned.The device was returned opened without packaging.A visual inspection found the the upper jaw was detached.The upper jaw was not returned for evaluation.The device was returned outside of packaging and no packaging was returned.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 concluded this was a repeat issue.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 one undated photo of the device was provided for review and confirm the reported.Per the customer feedback form, ¿all material was removed and accounted for.¿ the procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A review of the customer provided image shows a detached upper jaw.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.

• Brand Name: FIRSTPASS MINI LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 13101449
• MDR Text Key: 283814818
• Report Number: 3006524618-2021-01073
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694565
• UDI-Public: 00885556694565
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: 72290129
• Device Catalogue Number: 72290129
• Device Lot Number: 2068441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/01/2022; 07/13/2022
• Supplement Dates FDA Received: 02/02/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention