Brasseler USA 5004057M0Recalls & reported problems
Peter Brasseler Holdings, LLC · KM166-10-01 STERILE TWIST DRILL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887919448181), received between Jul 19, 2022 and Oct 24, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
5/64 X 5 STERILE TWIST DRILL BIT TIP BROKE OFF MID-DRILL INSIDE PATIENT'S PATELLA DURING QUAD TENDON REPAIR. FOREGIN BODY WAS UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 17995660 ↗InjuryJul 19, 2022Material Fragmentation; Material Fragmentation
AT 1:29 PM WHILE THE ATTENDING SURGEON WAS DRILLING THE FEMUR TO TIE THE TAGGING STITCH, THE DRILL BROKE INSIDE THE PATIENT'S FEMUR. THE TEAM WAS UNSUCCESSFUL REMOVING IT. APPROXIMATELY 1 INCH WAS BROKEN OFF IN THE FEMUR. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15052653 ↗
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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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