MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number	22-4038
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual evaluation showed one device was returned but not in any original packaging.One side of the suture capture has fractured from the upper jaw.The suture capture piece was returned.Bio debris is present.No other visual deficiencies.A functional evaluation showed pulling the lever will close the aligned jaws and deploy the suture passer needle as intended.These findings are related to the reported event.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 fractured suture capture include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences ((1) excessive force, (2) tissue thickness, (3) damage or debris on 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.
Event or Problem Description
It was reported that during an arthroscopy, the jaw of firstpass could not close fully and encounter issue to deploy for the cuff ¿biting¿ with few attempts.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Common Device Name: PASSER
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22993784
• Report Number: 3006524618-2025-00493
• Device Sequence Number: 9519199
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• 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
• Report Date (Section B): 09/08/2025

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: 22-4038
• Device Lot Number: 2167298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 10/28/2024
• 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