S-ROM 53-5506Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295172536), received between Mar 4, 2021 and Feb 2, 2024 — 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 16, 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.

• MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY VIA THA WITH S-ROM REAMER AND T HANDLE IN QUESTION. DURING THE SURGERY, IT WAS USED AS A STARTER BY CONNECTING S-ROM REAMER AND T-HANDLE, BUT THE CONNECTION SOMETIMES CAME OFF, MAKING IT DIFFICULT TO USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633083 ↗
• MalfunctionMar 4, 2021Break; Break

  LOAN INSTRUMENT BREAKAGE, INTRA-OPERATIVELY, PRODUCT CODE 535506 - 6MM SROM STRAIGHT REAMER DURING REAMING THE REAMER BROKE INTO 2 PIECES, BOTH PIECES WERE REMOVED FROM THE PATIENT. AN ADDITIONAL INCISION WAS MADE TO REMOVE 1 PART.

  Patient problems: Insufficient Information

  MAUDE report 11414439 ↗