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SOLUTION SYSTEM 2108-24-000Recalls & reported problems

Depuy Orthopaedics, Inc. · SOLUTION SYSTEM THINSHAFT REAMER 12mm DIA · Class 1

All models of SOLUTION SYSTEM (64)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295087007), received between Sep 29, 2021 and Nov 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 16, 2026.

Most reported problems

Device problems

  • Failure to Cut2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionNov 7, 2021Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT THE REAMERS ARE DULL AND NEED REPLACING. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12758663 ↗
  • MalfunctionSep 29, 2021Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT THE REAMERS ARE DULL AND NEED REPLACING. SHIP REPLACEMENTS P1 TO (B)(6) WAREHOUSE. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12546661 ↗

Other REAMER devices

All REAMER devices →

Sources and updates

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