S-ROM 2576-20-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295146759), received between Apr 11, 2018 and Apr 17, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (6 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.

• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCTS HAVE REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS WERE COMPLAINING ABOUT INSTRUMENT BEING DULL, ILLEGIBLE, AND GENERALLY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909295 ↗
• MalfunctionMar 23, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665344 ↗
• MalfunctionAug 23, 2021Material Integrity Problem; Material Integrity Problem

  INSTRUMENTS DAMAGED FROM PREVIOUS SROM CASES. FOUND TO BE DAMAGED AT THE CASE. X2 DAMAGED SLEEVE TRIALS NEED REPLACING -DAMAGED. X1 11X16 STEM TRIAL NEEDS REPLACING -DAMAGED. X1 PLASTIC FRAME SLEEVE NEEDS REPLACING -IS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356573 ↗
• MalfunctionApr 6, 2020Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT INSTRUMENTS ARE BROKEN AND CAN¿T BE READ.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929217 ↗
• MalfunctionApr 6, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES ARE DAMAGED AND CAN¿T BE READ. NO LOT NUMBERS CAN BE READ. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928306 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVES CAN¿T BE READ OR USED OR DAMAGED. NOT USED IN A CASE. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924056 ↗
• MalfunctionApr 3, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES CAN'T BE READ OR USED OR DAMAGED. NOT USED IN A CASE. CAN'T READ LOT NUMBERS SO DON'T ASK FOR THEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919366 ↗
• MalfunctionFeb 25, 2020Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE EITHER DIFFICULT TO IMPOSSIBLE TO READ THE SIZE. THIS IS A SAFETY CONCERN FOR THE SURGEON WHO CAN'T EASILY DETERMINE THE SIZE OF THE TRIAL SLEEVE BEING INSERTED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752087 ↗
• MalfunctionApr 18, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SROM SLEEVES HAVE BECOME WORN FROM SAWING AND NEED REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439634 ↗
• MalfunctionApr 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IDENTIFYING MARKINGS FOUND TO BE DAMAGED IN POST CLEANING INSPECTION, IT IS UNREADABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421552 ↗