NA 72203415Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554023527), received between Sep 11, 2020 and May 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• MalfunctionMay 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE WING SCREW OF THE ARM BOARD TENET WAS STRIPPED AND WON'T TIGHTEN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817215 ↗
• MalfunctionFeb 17, 2021Unstable

  IT WAS REPORTED THAT THE TENET KNOB WAS BROKEN AND THERE WAS LOSS OF TRACTION. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT 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 11339909 ↗
• MalfunctionNov 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE ARM BOARD OF THE "NON OPERATIVE ARM BOARD TENET" WAS COMING APART OF THE METAL PART. 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 10912527 ↗
• MalfunctionNov 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE ARM BOARD OF THE "NON OPERATIVE ARM BOARD TENET" WAS COMING APART OF THE METAL PART. 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 10912504 ↗
• MalfunctionSep 11, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE ARM BOARD TENET WAS NOT HOLDING. 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 10524642 ↗