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

Model Number 72290129

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a meniscal root repair, with a firstpass mini suture passer, the surgeon was using the device as per technique, there was sufficient room in the knee for the needle to pass.It was noticed that the upper jaw was not holding onto the tape and kept dropping it, after 5 passes the top jaw would not grasp the tape and the top retrieval jaw snapped off, it was located it and removed from the patient's knee using an ii machine and an arthroscopic grasper.The procedure was successfully completed with no delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H10 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 no 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 smith and nephew has not received the device/relevant clinical documentation to perform a thorough medical investigation nor to determine the clinical root cause of the reported failure.Based on the information provided, the top retrieval jaw snapped off, it was located it and removed from the patient's knee using an ii machine and an arthroscopic grasper.According the report, the surgery completed without delay using a back-up device.Since no other patient complications were reported, no further clinical/medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.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 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: 13549020
• MDR Text Key: 285743528
• Report Number: 3006524618-2022-00059
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• 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): Other