S-ROM 2576-04-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295145486), received between Jun 29, 2018 and Feb 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionFeb 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REAM WITH THE ANGLED REAMER THE REAMER GOT STUCK IN THE TRIANGLE MILLER, SO THE SALES REP OPENED ANOTHER SET BECAUSE HE WANTED TO BURY THE ANGLED REAMER DOWN MORE AND THE SAME THING HAPPENED WITH THE 2ND SET HE OPENED. THE REAMERS NOW WON¿T MOVE FREELY WITHIN THE ANGLED MILLER, SO BOTH THE REAMER AND THE ANGLED MILLERS NEEDS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728571 ↗
• MalfunctionNov 9, 2023Material Discolored; Naturally Worn; Illegible Information; Material Discolored; Naturally Worn; Illegible Information

  IT WAS REPORTED, THAT THE INSTRUMENTS SIZING AND COLOR MARKINGS ARE FADED, WORN AND DIFFICULT TO SEE. DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101170 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT THE SCRUB TECH NOTICED THE IMPACTOR HANDLE WAS STRIPPED AND THAT THE COLOR BAND FELL OFF THE REAMER. INSTRUMENTS WERE NOT USED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277819 ↗
• MalfunctionApr 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SROM MILLER FRAME NO LONGER ALLOWS FOR SMOOTH REAMING OF THE CALCAR. UNABLE TO TELL IF IT¿S ONLY THE FRAME OR THE DRILLS. BOTH APPEAR TO HAVE SIGNIFICANT WEAR. NO INSTRUMENTS BROKE INTO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740073 ↗
• MalfunctionJun 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ANGLED REAMER (2 SIZES) AND ANGLE MILLER NOT WORKING PROPERLY. REAMER CATCHING UP ON ANGLE MILLER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651049 ↗