N/A 012310Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010024527), received between Oct 24, 2018 and Apr 5, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE LEG HOLDER WAS NOT HOLDING IN PLACE DURING SET UP OR INSPECTION FOR A KNEE SCOPE. THERE WAS A SMITH AND NEPHEW DEVICE AVAILABLE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS 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 11613136 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE ACUFEX LEG HOLDER WAS BROKEN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11526912 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE LEG HOLDER WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11489960 ↗
• MalfunctionMar 9, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LEG HOLDER SCREW COULD NOT BE CLOSED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE POSITIONING LOCK WAS SEIZED AND IT COULD NOT BE REMOVED WHICH MAKES IT A REPORTABLE EVENT. 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 11446563 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT THE WELD ON THE LEG HOLDER CAME OFF. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO DELAYS OCCURRED. 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 11221336 ↗
• MalfunctionOct 7, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE MECHANISM OF THE LEG HOLDER GOT LOOSE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10643175 ↗
• MalfunctionSep 3, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE LEG HOLDER DID NOT TIGHT DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10489209 ↗
• MalfunctionJul 11, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE HOLDER LEG WAS BENT AND IT WAS MISSING A PIECE; HENCE, IT WAS NOT LOCKING IN POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10261809 ↗
• MalfunctionJun 24, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THE LEG HOLDER WAS NOT ABLE TO LOCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10190303 ↗
• MalfunctionApr 1, 2019Device Slipped

  IT WAS REPORTED THAT DURING A KNEE SCOPE THE DEVICE WAS NOT HOLDING. NO DELAY AND NO BACK-UP DEVICE AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471469 ↗
• MalfunctionOct 24, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE WILL NOT TIGHT DURING THE PROCEDURE. THERE WAS NO SMITH & NEPHEW BACKUP DEVICE. PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001088 ↗