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

Catalog Number 72290128

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a procedure, it was found that the firstpass mini sterilization tray was not sealed properly and was opened from the beginning.The procedure was completed using a smith and nephew back up device.There was no surgical delay and no further complications were reported.

Manufacturer Narrative

H10 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 no similar reported events.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 review of the packaging process found that the packaging assembler must verify that the seal in the tray is appropriate and if the sterile barrier is compromised the the unit must be rejected.Please refer to the instructions for use for precautions and warnings related to the use of the device.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 STRAIGHT
• 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: 18635830
• MDR Text Key: 335414306
• Report Number: 3006524618-2024-00045
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290128
• Device Lot Number: 2133872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/08/2024
• Date Device Manufactured: 10/05/2023
• 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