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

Catalog Number 72290129

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported that during a shoulder scope with bankart repair; a firstpass mini was used successfully to place the first suture through the labrum; however when it was the second suture it was noticed by the physician at the moment of retrieving the device from the surgical site that the small metal side of the suture trap was missing; which was not retrieved from the patient.Surgery resumed after a non-significant delay with a back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder scope with bankart repair; a firstpass mini was used successfully used to place the first suture through the labrum; however when it was the time for the second suture, it was noticed by the physician at the moment of retrieving the device from the surgical site that the small metal side of the suture trap was missing; it was not stablished whether the piece of the suture capture stayed behind in the surgical site.Surgery resumed after a non-significant delay with a back-up device.No further complications were reported.

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 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 MINI LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 17677217
• MDR Text Key: 322610526
• Report Number: 3006524618-2023-00347
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694565
• UDI-Public: 00885556694565
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 72290129
• Device Lot Number: 2099937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 09/06/2023; 10/24/2023
• Supplement Dates FDA Received: 09/11/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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