BRISTOW LATARJET 285325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705018147), received between Jul 19, 2021 and Jul 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionJul 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED FROM THE AFFILIATE THAT THE LATARJET SOLID SCREWDRIVER DEIVICE BOLTS THAT HELD THE DRIVER SHAFTS IN THE HANDLES CAME LOOSE OR HELD DEBRIS UNDER THEM. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP OF THE SCREWDRIVER WAS DEFORMED AND BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191739 ↗