S-ROM 2576-02-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295145363), received between Feb 20, 2020 and Nov 9, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (7 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 8 most recent of 8 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 18101347 ↗
• 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 16681674 ↗
• MalfunctionJul 26, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A CASE THE SCREWS FROM AN SROM INSTRUMENT CAME OFF WHICH CAUSED THE INSTRUMENT TO SLIDE AND MAKE DIFFICULT TO REMOVE. WE ALSO NOTICED A MILLING DEVICE (WE DIDN'T USE IT BUT NOTICED IT) HAS MANY METAL FRAGMENTS ON IT AND THE MILLING AND NOTICEABLE BURRS OUT OF IT AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103919 ↗
• 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 10036509 ↗
• 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 10002012 ↗
• 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 10000542 ↗
• MalfunctionMar 24, 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 9875117 ↗
• 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 9732490 ↗