S-ROM 2576-18-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295146636), received between Sep 29, 2017 and Apr 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE SROM PRODUCTS BELOW HAVE REACHED END OF LIFE. THEY HAVE BEEN IN SERVICE FOR NEARLY 20 YEARS. THE SURGEON COMPLAINED THAT THE INSTRUMENTS ARE SO WORN, THEY ARE UNREADABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015140 ↗
• 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 24909004 ↗
• MalfunctionMar 23, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665103 ↗
• MalfunctionMar 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TRIAL SLEEVE IS WORN. PATIENT STATUS/ OUTCOME / CONSEQUENCES ? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF ? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970677 ↗
• 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 10001996 ↗
• 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 9919363 ↗
• 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 9919362 ↗
• 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 9919359 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; 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 9919356 ↗
• MalfunctionFeb 27, 2020Material Twisted/Bent; Scratched Material; Illegible Information; Material Twisted/Bent; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE DIFFICULT TO IMPOSSIBLE TO READ SIZING DUE TO WEAR AND TEAR AND NORMAL EVERYDAY USE. THE NEED TO BE REPLACED SO THAT THE SURGEON IS ABLE TO SAFELY DETERMINE THE SIZE OF THE TRIAL BEING USED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765949 ↗
• MalfunctionFeb 25, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; 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 9752892 ↗
• MalfunctionDec 20, 2019Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT DURING TRIAL IMPLANTATION, THE S-ROM 18F LG SLEEVE TRIAL WAS FOUND TO HAVE DAMAGE TO ITS TOP. ALL OF THE IDENTIFYING NUMBERS HAVE BEEN SHAVED OFF OF THE SURFACE. THIS EVENT DID NOT TAKE PLACE DURING THE CASE AND THE TRIAL WAS NOT USED. LOT NUMBER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505973 ↗
• 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 7439451 ↗
• MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.

  Patient problems: No Information

  MAUDE report 6903987 ↗