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

Catalog Number	72290130
Medical Device Problem Codes	Break (1069); Unstable (1667)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a meniscal repair root, it was noticed that the firstpass mini broke, and the body was loose.The procedure was resumed, with a delay of less than 30 minutes, using the same device.No further complications were reported.
Event or Problem Description
It was reported that, during a meniscal repair root, it was noticed that the firstpass mini broke, and the body was loose.The broken piece was successfully removed from the patient using graspers.The procedure was resumed, with a delay of 20 minutes, using the same device.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected information in b1, b5, h1 and h6: health effect - clinical code and impact code.
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).H11 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.A clinical evaluation states that fluoroscopic images were provided for review; while the images confirm the reported breakage, they do not indicate a root cause for the reported event and that the device ifu does note, ¿as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.Excessive force can result in failure.¿ a review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FIRSTPASS MINI RIGHT
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23073372
• Report Number: 3006524618-2025-00508
• Device Sequence Number: 17340029
• Product Code: NBH
• UDI-Device Identifier: 00885556694572
• UDI-Public: 885556694572
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72290130
• Device Lot Number: 2153269
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 09/14/2025; 10/21/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/25/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown