S-ROM 2576-02-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295145332), received between Dec 26, 2018 and May 7, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036545 ↗
• MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036533 ↗
• MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036519 ↗
• MalfunctionSep 19, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT THE SURGEON COMPLAINED ABOUT THE SROM AUXILLIARY TRAY INSTRUMENTS. THERE ARE THREE CONICAL REAMERS IN THAT TRAY. UNFORTUNATELY I DO NOT KNOW THE PART NUMBERS. TWO COMPLAINTS. THE MARKINGS ARE TERRIBLY WORN AND EXTREMELY DIFFICULT TO READ WHICH MADE THE CASE CHALLENGING. THE REAMERS HAD A VERY DIFFICULT TIME CUTTING INTO THE BONE AND PROBABLY NEED TO BE SHARPENED. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9086729 ↗
• MalfunctionDec 26, 2018Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  EXCESSIVE WEAR AND LACK OF SHARPNESS OF SOME S-ROM LOANER SET ESPECIALLY WHEN SOILED WITH BLOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196835 ↗