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

Catalog Number	72290129
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the specialist introduced the firstpass mini into the joint portal, the space area was not tight.While grabbing the root of the meniscus, the upper jaw metal tip came out of the joint.The broken piece was successfully retrieved using arthroscopic graspers.The procedure was completed using a smith and nephew back up device.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the suture capture of the device appears to be detached.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.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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (an impact event to the device inconsistent with normal use or excessive force to the device).Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: FIRSTPASS MINI LEFT
• Common Device Name: 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: 21627828
• Report Number: 3006524618-2025-00116
• Device Sequence Number: 8266427
• Product Code: NBH
• UDI-Device Identifier: 00885556694565
• UDI-Public: 885556694565
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72290129
• Device Lot Number: 2143919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown