S-ROM NOILES 2163-11-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295093602), received between Aug 28, 2018 and Apr 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, IT WAS OBSERVED THAT AN UNKNOWN PIN DEFORMED INSIDE THE S-ROM CUTTING BLOCK. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828661 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT CAME WITH THE TIP OF A BROKEN PIN INSIDE THE SMALL FEMORAL CUTTER. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712716 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW WAS STUCK IN CUTTING BLOCK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11058732 ↗
• MalfunctionFeb 13, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ALL INSTRUMENTS ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8335348 ↗
• MalfunctionJan 23, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PIN BROKE OFF IN CUTTING GUIDE AND IT WAS STUCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270779 ↗
• MalfunctionAug 28, 2018Naturally Worn; Naturally Worn

  ROUTINE INSPECTION OF INSTRUMENTS INDICATED FRAYED METAL ON ONE INSTRUMENT, AND A MISSING ORANGE INSERT ON A SECOND INSTRUMENT. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822055 ↗
• MalfunctionAug 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS STATED THAT CROSS PIN STUCK IN SROM CUTTING BLOCK, UNIVERSAL HANDLE TIP FRACTURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822042 ↗