S-ROM 53-6859Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295173168), received between Jul 26, 2019 and Jul 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL RECEIVED DIRTY INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014393 ↗
• MalfunctionJul 26, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT MULTIPLE SROM REAMERS WERE DAMAGED DURING A SURGERY WITH SURGEON. THE REAMERS WERE USED TO "REAM" THROUGH SOME HARDWARE LEFT IN A HIP. SINCE THE REAMERS WERE USED TO DO THIS, MANY OF THEM HAVE BEEN DAMAGED AND NEED TO BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831118 ↗