SURGICAL ASSISTANT 7209451Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010468635), received between Nov 12, 2018 and Mar 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unstable” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE LEG HOLDER FAILED TO HOLD THE LEG IN THE PLACE. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440974 ↗
• MalfunctionFeb 19, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE LEG HOLDER WON¿T LOCK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347899 ↗
• MalfunctionOct 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE LEG HOLDER WOULD NOT LOCK AND IT WOULD NOT STAY LOCKED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10624630 ↗
• MalfunctionMay 7, 2019Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WOULD NOT LOCK. THE DEVICE WOULD NOT HOLD PATIENT LEG IN POSITION WHILE ALL ARTHROSCOPY INSTRUMENTS INSIDE THE KNEE. THE PROCEDURE CONTINUED WITH THE USE OF THE DEVICE, SINCE IT WAS UNDER STERILE DRAPE AND VERY DIFFICULT TO MAINTAIN STERILITY AND ¿SWITCH OUT¿ DURING THE CASE. THERE WAS NO DELAY AND PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8586222 ↗
• MalfunctionNov 12, 2018Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE IS NOT STAY LOCKED. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060473 ↗