RELIANCE 48361150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327268928), received between Jan 10, 2018 and Jan 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “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 16, 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.

• MalfunctionJan 10, 2018Bent; Break; Component Falling; Material Separation; Bent

  IT WAS REPORTED THAT; DURING AN ALIF, THE DISTRACTOR WAS HANDED TO THE SURGEON. DURING THE INSTRUMENT HANDOFF, THE SURGEON NOTICED THERE WAS NO TENSION ON THE HANDLE OF THE INSTRUMENT. HE LOOKED DOWN AND NOTICED THE HANDLE HAD SEPARATED FROM THE BODY OF THE INSTRUMENT AND THE CORRESPONDING SCREW AND SPRING FELL OUT OF THE HANDLE. AT THE TIME NO ONE WAS INJURED AND LUCKILY WE HAD A SECOND DISTRACTOR AS BACKUP SO WE QUICKLY SWITCHED TO THE BACK UP DISTRACTOR... CASE WAS THEN PERFORMED FLAWLESSLY WITH NO ISSUES. IT WAS APPARENT THAT THE SMALL PIN AT THE JOINTED PORTION OF THE DISTRACTOR HAD BROKEN ALONG WITH THE SPRING, WHICH CAUSED THE ISSUE. THIS MUST HAVE HAPPENED DURING STERILIZATION BECAUSE IT WAS NOT NOTICED DURING CASE PREP OR WHEN THE INSTRUMENTS WERE HANDED OFF TO SPD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180823 ↗