ENDOSKELETON® TA 2112-9314Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375002345), received between Feb 19, 2018 and Feb 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2018Device Reprocessing Problem; Device Contamination with Body Fluid; Contamination /Decontamination Problem; Device Reprocessing Problem; Device Contamination with Body Fluid; Contamination /Decontamination Problem

  A SALES REPRESENTATIVE REPORTED A MALFUNCTION WITH AN INSTRUMENT DURING THE SURGEON'S SECOND OF TWO TAS CASES. THREE OF THE SIX TRAYS THAT WERE PROCESSED BY THE (B)(6)DEPARTMENT HAD "BIO-BURDEN" IN THEM. THE FIRST BREAK IN STERILITY WAS CAUGHT WHILE SETTING UP THE ROOM AND THE PAN. INSTRUMENT #2 WAS REMOVED FROM THE FIELD AND THE INSTRUMENTS WERE FLASH AUTOCLAVED. THE SECOND INCIDENT OCCURRED WHEN THE SCRUB TECH REACHED INTO INSTRUMENT #1 TO PULL OUT THE STRAIGHT AWL. WHEN THE SCRUB TECH LIFTED THE AWL OUT OF THE TRAY A FOREIGN BODY FELL OFF THE BOTTOM OF THE HANDLE AND INTO THE TRAY. IT WAS DIFFICULT TO DETERMINE WHAT IT WAS. IT LOOKED LIKE A PIECE OF A LEAF OR A PIECE OF RUST THAT MAY HAVE BEEN IN THE PAN. IT WAS BROUGHT TO THE SURGEON'S ATTENTION, AND HE WAS OF THE MINDSET THAT IT WAS A "STERILE BIO-BURDEN" AND CONTINUED TO PROCEED WITH THE SURGERY. THE THIRD INCIDENT OCCURRED WHEN THE SURGEON ASKED FOR AN EXTRA-LARGE 12 DEGREE 14 MM TRIAL (HE HAD ALREADY USED THE 7 DEGREE TRIAL AT THIS TIME). WHEN THE TECH PULLED THE TRIAL OUT OF THE TRAY IT WAS CONFIRMED THERE WAS DEFINITELY DRIED BLOOD ON THE TRIAL AND IN THE TRAY. THE 12 DEGREE TRAY WAS NOWHERE NEAR THE REST OF THE STERILE F

  Patient problems: No Patient Involvement

  MAUDE report 7281290 ↗