S-ROM 2576-16-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295146476), received between Apr 18, 2018 and Apr 17, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCT HAVE REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS WERE COMPLAINING ABOUT INSTRUMENT BEING DULL, ILLEGIBLE, AND GENERALLY WORN. THERE WILL BE MULTIPLE PAGES ON THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909557 ↗
• MalfunctionMar 24, 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 24681357 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED THAT THE SROM SLEEVE TRIAL 16F LARGE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253433 ↗
• InjuryOct 26, 2022Improper or Incorrect Procedure or Method; Scratched Material; Improper or Incorrect Procedure or Method; Scratched Material

  BROKEN SROM SLEEVE TRIAL. SURGEON HIT THE SLEEVE WITH THE STEM TRIAL INCORRECTLY CAUSING DENTS IN THE SLEEVE TRIAL.

  Patient problems: Limb Fracture

  MAUDE report 15672933 ↗
• 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 10002006 ↗
• MalfunctionApr 1, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED AND ARE DAMAGED. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912537 ↗
• 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 9765952 ↗
• MalfunctionOct 23, 2019Scratched Material; Scratched Material

  ITEMS HAVE BEEN FLAGGED DURING THE STERILIZATION PROCESS. NO FURTHER INFORMATION PROVIDED. ITEMS HAVE BEEN HANDED IN AT OUR WAREHOUSE/LOAN KIT DEPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226433 ↗
• 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 7439524 ↗