S-ROM 53-4702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295172055), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 injury.

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 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.

• InjuryOct 25, 2019Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT THE SHAFT PILOT WAS COME OFF FROM THE CONE REAMER (P/N: 534702) WHEN THE SURGEON TOOK THE INSTRUMENTS OUT FROM MEDULLARY CAVITY DURING THE THA SURGERY WHICH WAS COMBINED WITH OSTEOTOMY SURGERY ON (B)(6) 2019 AND THE SHAFT PILOT WAS REMAINED IN MEDULLARY CAVITY. IT WAS DIFFICULT TO REMOVE THE SHAFT PILOT, AND IT WAS REMOVED BY PERFORMING OSTEOTOMY FIRST. THE SURGEON CONSIDERED IT HAD NOT BEEN CONNECTED PROPERLY AND ATTEMPTED USING IT AGAIN AFTER REATTACHED THEM HOWEVER THE SAME ISSUE OCCURRED. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. DR¿S VIEW: IT WAS ABLE TO REMOVE THE SHAFT PILOT AFTER THE OSTEOTOMY, BUT IT MAY HAVE BEEN DIFFICULT TO REMOVE IF IT OCCURRED DURING NORMAL SURGERY. THERE WAS A POSSIBILITY OF IT WAS HAPPENED BECAUSE IT MIGHT BE EASILY DETACHED DUE TO DETERIORATION OVER TIME OF THE JOINT PART. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9240443 ↗