SUMMIT 2570-04-100Recalls & reported problems
Depuy (Ireland) · SUMMIT CALCAR PLANER SMALL · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Summit calcar planer, a bone-shaping surgical tool, has 193 reports, 2 injuries and no deaths. Most reports describe the planer failing to cut because its blades are dull, and some describe parts breaking off or the tool being bent. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 193
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 10603295143178), received between Jul 24, 2017 and Feb 4, 2026 — classified as 2 injuries, 191 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (113 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut113
- Dull, Blunt60
- Naturally Worn10
- Break9
- Material Twisted/Bent5
- Device-Device Incompatibility3
- Improper or Incorrect Procedure or Method2
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions114
- No Consequences Or Impact To Patient67
- Insufficient Information10
- No Code Available3
- Limb Fracture1
- Nerve Damage1
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE A SHARD OF METAL HAS BROKEN OFF FROM ONE OF THE CUTTING EDGES OF THE PLANER. SURGEON HAD FINISHED USING IT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261383 ↗MalfunctionOct 27, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE CALCAR PLANER SEEMED WARPED AND DID NOT PLANE THE CUT SURFACE SMOOTHLY. FURTHER THE +5 TRIAL SPACER AND THE 45X28 HEADS WERE SEVERELY "SCUFFED AND BATTERED" IN THE SET. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392058 ↗InjuryJun 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DUE TO THE CALCAR REAMERS BEING BLUNT, A PATIENT HAS SUSTAINED CALCAR FRACTURE(S).
Patient problems: Limb Fracture
MAUDE report 22331814 ↗MalfunctionOct 30, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE SURGEON COMPLAINED CALCAR PLANER WAS DULL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20568566 ↗MalfunctionSep 30, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333847 ↗MalfunctionSep 24, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294735 ↗MalfunctionSep 23, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED ON (B)(6) 2024 THAT THE CALCAR PLANER IS DULL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20279870 ↗MalfunctionSep 23, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED ON SEPTEMBER 12, 2024 THAT THE CALCAR PLANER IS DULL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20279867 ↗MalfunctionSep 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE REAMER IS DULL.
Patient problems: Insufficient Information
MAUDE report 20180397 ↗MalfunctionAug 14, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE SURGEON COMPLAINED THE SMALL CALCAR PLANERS WERE DULL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983226 ↗MalfunctionAug 14, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE SURGEON COMPLAINED THE SMALL CALCAR PLANERS WERE DULL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983225 ↗MalfunctionAug 1, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR REAMER SHOULD BE REPLACED. THE CALCAR IS NOT SHARP, THEREFORE PROBABLY THE SURGEON PUT EXTRA EFFORT AND DAMAGED THE INSTRUMENT. NO PATIENT HARM, NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19885712 ↗MalfunctionJul 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS DULL.
Patient problems: Insufficient Information
MAUDE report 19826304 ↗MalfunctionJul 17, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THATTHE CALCAR PLANAR WAS DULL. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19763309 ↗MalfunctionJun 27, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENTS WERE BLUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19627374 ↗MalfunctionApr 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANER WAS DULL. IT WAS NEEDS TO BE REPLACED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19078277 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073975 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073974 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073969 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073962 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073435 ↗MalfunctionMar 26, 2024Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION RECEIVED. STATES, THAT ITEM DAMAGED. AS, THE NECK SEGMENTS WILL NOT ENGAGE WITH THE NECK SEGMENTS/BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978981 ↗MalfunctionMar 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANER IS DULL AND NEEDS REPLACEMENT. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18971783 ↗MalfunctionJan 5, 2024Failure to Cut; Failure to Cut
THE SMALL CALCAR REAMER IS BLUNT, A LARGER ONE WAS USED DURING THE CASE. NO HARM CAUSED TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18457363 ↗MalfunctionJan 2, 2024Improper or Incorrect Procedure or Method; Material Integrity Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18430329 ↗
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 2570-04-200Depuy (Ireland) · Bone mill91 reports
- NA L94010Depuy (Ireland) · Bone mill22 reports
- LPS 2987-70-001Depuy (Ireland) · Bone mill5 reports
- NA 4861-00-010Depuy (Ireland) · Bone mill4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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