NA 4861-00-010Recalls & reported problems
Depuy (Ireland) · CALCAR PLANER SMALL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295513933), received between Dec 7, 2022 and Oct 28, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
- Failure to Cut2
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL AND NEED REPLACEMENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20544307 ↗MalfunctionOct 28, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL AND NEED REPLACEMENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20544280 ↗MalfunctionApr 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DM HEAD TRIAL INSERTION TOOL IS GETTING STUCK IN THE TRIAL HEADS. ALSO THE SMALL CALCAR PLANAR WILL NOT ATTACH TO THE POWER ADAPTER.
Patient problems: Insufficient Information
MAUDE report 19162439 ↗MalfunctionDec 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STATED THE TOLERANCE ON PLANAR SHAFT IS TOO TIGHT ON BROACH TRUNION CAUSING DAMAGE TO BROACH. BROACH HAS VISIBLE WEAR ON TRUNION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932026 ↗
Other Bone mill devices
- AML EXCEL 2001-48-000Depuy (Ireland) · Bone mill472 reports
- AML EXCEL 2001-47-000Depuy (Ireland) · Bone mill220 reports
- AML EXCEL 2001-49-000Depuy (Ireland) · Bone mill212 reports
- SUMMIT 2570-04-100Depuy (Ireland) · Bone mill193 reports
- SUMMIT 2570-04-200Depuy (Ireland) · Bone mill91 reports
- NA L94010Depuy (Ireland) · Bone mill22 reports
- LPS 2987-70-001Depuy (Ireland) · Bone mill5 reports
- NA 2001-80-503Depuy Orthopaedics, Inc. · Bone mill3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page