S-ROM 2576-16-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295146483), received between Mar 29, 2019 and Mar 24, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 24675528 ↗
• MalfunctionMay 25, 2021Scratched Material; Scratched Material

  IT WAS REPORTED AS "INSTRUMENTS WERE USED IN SURGERY. UPON INSPECTION OF THOSE INSTRUMENTS THIS MORNING, (B)(6) , WE NOTICED SOME DEFECTS IN THE TWO SLEEVE TRIALS MAKING IT DIFFICULT TO USE WITH THE "SLEEVE INTRODUCER" HANDLE. WE ALSO INSPECTED THE REAMER HANDLE AND IT WAS DIFFICULT TO LOCK ON THE CONICAL REAMERS. THESE ISSUES WERE NOT MENTIONED IN SURGERY, HOWEVER, AFTER SPEAKING WITH THE SURGICAL TECH TODAY, (B)(6), HE ASKED ME TO TAKE A LOOK." NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875872 ↗
• 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 9912541 ↗
• MalfunctionNov 7, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  FOUND A CONTAMINANT WHITE POWDERY SUBSTANCE ON THEIR SROM HIP INSTRUMENTS FOLLOWING THE WASH CYCLE. IT AFFECTED MULTIPLE INSTRUMENTS ¿ PRIMARILY STEM TRIALS THAT ARE ALUMINIUM BASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290348 ↗
• MalfunctionMar 29, 2019Device Markings/Labelling Problem; Naturally Worn; Scratched Material; Device Markings/Labelling Problem; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE OFFICE SETS WERE WORN OUT AND CANNOT READ ETCHING. DID NOT EFFECT A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466180 ↗