Brasseler USA 5003989M0Recalls & reported problems
Peter Brasseler Holdings, LLC · KM3-111 25.0 X 9.0MM · Class 1
Data updated Oct 18, 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 00887919445869), received between Dec 9, 2024 and Mar 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
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.
MalfunctionMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DOCTOR WAS USING THE BLADE FOR AN ACL REPAIR SURGERY, CUTTING TIBIA AND PATELLA FOR BTB AUTOGRAFT. THE BLADE BROKE AT THE HUB. THEY CONTINUED TO USE THE SAME PART NUMBER, AND THE OTHER BLADES BROKE AS WELL DURING THIS PROCEDURE. THE REPORTED NUMBER OF BLADES BROKEN VARIED FROM FOUR TO FIVE. THESE BLADES, AND THEIR PACKAGING, WERE DISCARDED. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21699964 ↗MalfunctionDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
DURING AN ACL REPAIR, THE BLADE BROKE WHEN TRYING TO CUT THE PATELLA. IT BROKE AT THE BASE OF THE BLADE WHERE THE BLADE ATTACHES TO THE POWER SYSTEM. THE PRODUCT WAS COMPLETELY REMOVED FROM THE PATIENT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887735 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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