BRISTOW LATARJET 285260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705017980), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 malfunction.

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

• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING AN OPEN SHOULDER REPAIR, IT WAS OBSERVED THAT THE LATERJET CORACOID K-WIRE, 150 MM BROKE WHEN THE SURGEON WAS DRILLING WITH IT. THE SALES REP REPORTED THAT THE DEVICE BROKE IN HALF OUTSIDE OF THE PATIENT AND NOTHING FELL INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES. THERE WAS A 15 MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER OR AGE OF THE DEVICE. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7722308 ↗