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S-ROM 53-6853Recalls & reported problems

Depuy (Ireland) · S-ROM REAMER BLUNT - STRAIGHT 13.5mm · Class 1

All models of S-ROM (185)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295173106), received between Dec 21, 2018 and Dec 21, 2018 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE NURSE NOTICED THAT BONE FRAGMENTS WERE ADHERING TO 3 S - ROM REAMERS (11.5, 12.5, 13.5) DURING INSTRUMENT CHECK PRIOR TO THE STERILIZATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8190580 ↗

Other REAMER devices

All REAMER devices →

Sources and updates

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