BRISTOW LATARJET 285295Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705018086), received between Sep 26, 2019 and Jul 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2021Corroded; Corroded

  IT WAS REPORTED FROM THE AFFILIATE THAT THE LATARJET TOP HAT SCREW DRIVER DEVICE BOLTS THAT HELD THE DRIVER SHAFT IN THE HANDLES CAME LOOSE AND HELD DEBRIS UNDER THEM. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD RUST ON THE ETCH OF THE DEVICE. 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 12191665 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING A LATARJET PROCEDURE THE SALES REP'S TOP HAT SCREWDRIVER WAS DROPPED AND THE TIP OF THE DEVICE BENT. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE AVAILABILITY OF THE DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125653 ↗