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Brasseler USA 5004048M2Recalls & reported problems

Peter Brasseler Holdings, LLC · KM166-00-01 5/64 X 5" TWIST DRL · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887919447917), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryMar 23, 2022Material Fragmentation; Material Fragmentation

    THE DOCTOR WAS DRILLING INTO THE PATELLA. THE DRILL BIT BROKE IN THE PATELLA. THE BROKEN PIECE WAS LEFT IN THE PATELLA. NO FOLLOW-UP WAS NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13862743 ↗

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Sources and updates

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