MAUDE Adverse Event Report: ARTHROCARE CORPORATION INTELLIO SHIFT WIRED FOOT PEDAL; ARTHROSCOPE

Catalog Number	72290011
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction, the yellow ablate pedal of an intellio shift foot pedal became stuck in the down or on position, the flow 50 wand stayed in the "on" mood and the only way to turn it off was by unplugging the footpedal from the intellio shift controller.The surgeon was able to keep the device away from any tissue so there was no harm to the patient.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference case-(b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use 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.

• Brand Name: INTELLIO SHIFT WIRED FOOT PEDAL
• Common Device Name: ARTHROSCOPE
• 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: 24241102
• Report Number: 3006524618-2026-00042
• Device Sequence Number: 15999374
• Product Code: HRX
• UDI-Device Identifier: 00885556805015
• UDI-Public: 885556805015
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K232290
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 72290011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/02/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown