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

Catalog Number	72290129
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a meniscal root repair, two small metal pieces of the upper jaw of the firstpass mini suture passer broke, when it was attempted to pass the suture through the patient's meniscus.The two metal fragments were recovered with approximately 30 minutes of delay to the case due to the need for a c-arm to locate the second piece.The procedure was completed using a s+n back up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 a1, a2, a3: patient information updated.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H11 a1: patient identifiers updated.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The suture capture has been disconnected from the upper jaw.The returned suture capture is fragmented into two pieces and is deformed.Bio debris is present.No other visual deficiencies.A functional evaluation showed pulling the lever will close the jaw and deploy the suture passer needle as intended.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 (excessive force, tissue thickness.Damage or debris in the device tip between passes).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: 21317812
• Report Number: 3006524618-2025-00041
• Device Sequence Number: 8620911
• Product Code: NBH
• UDI-Device Identifier: 00885556694565
• UDI-Public: 885556694565
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2025

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: 2143918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 02/12/2025; 03/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/12/2025; 02/18/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female