S-ROM 2576-02-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295145356), received between Dec 26, 2018 and Nov 9, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Material Discolored; Naturally Worn; Illegible Information; Material Discolored; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS SIZING AND COLOR MARKINGS ARE FADED, WORN AND DIFFICULT TO SEE. DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101376 ↗
• MalfunctionApr 5, 2023Material Discolored; Naturally Worn; Illegible Information; Material Discolored; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE SIZING MARKERS ARE TOO FADED AND WORN. THEY ARE DIFFICULT TO READ. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681684 ↗
• MalfunctionDec 3, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE SROM REAMER WAS DULL FROM REGULAR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925720 ↗
• 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 10036529 ↗
• 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 10036505 ↗
• MalfunctionApr 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THESE INSTRUMENTS HAVE EXCESSIVE WEAR AND ARE DIFFICULT TO READ. REP INDICATED "THAT THEY NEED TO BE REPLACED". NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002009 ↗
• MalfunctionApr 27, 2020Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT WEAR AND TEAR, UNABLE TO READ IN SURGERY. SALES REPRESENTATIVE INDICATED NEED FOR REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000540 ↗
• MalfunctionMar 30, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. SURGEON IS CONCERNED THIS IS A PATIENT SAFETY ISSUE AND INSTRUMENTS SHOULD BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900823 ↗
• MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732488 ↗
• 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 8196864 ↗