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

Catalog Number 72290129

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported that during a meniscal repair surgery, the capture mechanism in the top jaw of the firstpass broke and part of it disengaged from the top jaw of the passer.Most of the broken pieces were removed using an arthroscopic grasper, but some small pieces were left inside the patient's knee.The procedure was successfully completed with non-significant surgical delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H10: h6: impact code updated.

Manufacturer Narrative

Internal complaint reference: (b)(4).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.A clinical review states no clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported breakage could not be determined.The firstpass mini¿s top jaw suture trap is composed of 17-7 condition a stainless steel.It is manufactured and intended as an externally communicating device that should have limited tissue/bone contact as long term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.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: 17990690
• MDR Text Key: 326354536
• Report Number: 3006524618-2023-00403
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

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: 2110662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 11/28/2023
• Supplement Dates FDA Received: 11/29/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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