SUMMIT 2570-04-200Recalls & reported problems
Depuy (Ireland) · SUMMIT CALCAR PLANER LARGE · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Depuy Summit calcar planer is a bone-cutting instrument used in hip surgery. Most reports say it became dull or blunt and failed to cut, sometimes after wear; one report links a calcar fracture to blunt reamers. There are 91 reports, no deaths and 1 injury. 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
- 91
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10603295143185), received between Apr 10, 2018 and Jun 25, 2025 — classified as 1 injury, 90 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (62 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut62
- Dull, Blunt23
- Naturally Worn9
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient23
- Insufficient Information4
- Limb Fracture1
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
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 22331802 ↗MalfunctionOct 4, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE DEVICES SUMMIT CALCAR PLANER-LARGE AND BROACH CORAIL AMT 13 HAD SUSTAINED SIGNIFICANT DAMAGE IN THE FORM OF GOUGES, SCRATCHES AND BURRED EDGES. THESE TWO COMPLAINED ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20372605 ↗MalfunctionJul 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS DULL.
Patient problems: Insufficient Information
MAUDE report 19826229 ↗MalfunctionJul 17, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANAR WAS DULL. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19763292 ↗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 19627165 ↗MalfunctionJun 10, 2024Failure to Cut; Failure to Cut
DURING ROUTINE TOTAL HIP SURGERY, SURGEONS IDENTIFIED THAT THE INSTRUMENTS HAD BECOME DULL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497281 ↗MalfunctionJun 6, 2024Failure to Cut; Failure to Cut
DURING ROUTINE TOTAL HIP SURGERY, SURGEONS IDENTIFIED THAT THE INSTRUMENTS HAD BECOME DULL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480606 ↗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 19073968 ↗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 19073965 ↗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 19073964 ↗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 19073961 ↗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 19073953 ↗MalfunctionNov 7, 2023Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18087701 ↗MalfunctionOct 19, 2023Failure to Cut; Failure to Cut
DURING SURGICAL PROCEDURE AT THE TIME OF MILLING IN THE CALCAR I PROCEED TO PASS ONE OF THE CALCAR REGULARIZERS REF (B)(4). AND DURING ITS OPERATION THIS IS DULL, I PROCEED TO PASS THE OTHER ONE THAT IS AVAILABLE IN THE EQUIPMENT REF (B)(4) AND IT DOES NOT SERVE TO CARRY OUT THE MILLING HOWEVER THIS NEITHER HAS EDGE. THEREFORE, THE SPECIALIST MANIFESTS HIS DISAGREEMENT SINCE THE INSTRUMENT DOES NOT WORK AND THIS REMODELLING HAD TO BE DONE MANUALLY WITH GOUGE AND SAW BLADE WHICH DELAYS THE PROCEDURE ABOUT 10 MINUTES MORE. SURGICAL PROCEDURE IS COMPLETED WITHOUT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17965339 ↗MalfunctionOct 12, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE REAMERS WERE DULL AND PMC IS SAYING THEY CANNOT BE SHARPENED. THE SURGEON IS ASKING FOR THEM TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17925345 ↗MalfunctionOct 12, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE REAMERS WERE DULL AND PMC IS SAYING THEY CANNOT BE SHARPENED. THE SURGEON IS ASKING FOR THEM TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17925088 ↗MalfunctionSep 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMER DULLED AND UNABLE TO REAM CALCAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821481 ↗MalfunctionSep 1, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT PLANER WAS DULL. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(6). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17670154 ↗MalfunctionSep 1, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT PLANER WAS DULL. PATIENT STATUS/ OUTCOME / CONSEQUENCES -- NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: -- UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY -- UNKNOWN, IP-01822111. DEVICE PROPERTY OF -- NONE, DEVICE IN POSSESSION OF -- NONE, IP-01822112. DEVICE PROPERTY OF -- NONE, DEVICE IN POSSESSION OF -- NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.-- TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17670124 ↗MalfunctionAug 7, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE SUMMIT LARGE CALCAR PLANERS ARE DULL FROM WEAR AND TEAR OVER TIME AND REQUIRE REPLACEMENT. THIS IS NOT OCCUR INTRA OP AND THEREFORE NO PATIENT ISSUES OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17470584 ↗MalfunctionAug 7, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE SUMMIT LARGE CALCAR PLANERS ARE DULL FROM WEAR AND TEAR OVER TIME AND REQUIRE REPLACEMENT. THIS IS NOT OCCUR INTRA OP AND THEREFORE NO PATIENT ISSUES OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17470577 ↗MalfunctionAug 7, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE SUMMIT LARGE CALCAR PLANERS ARE DULL FROM WEAR AND TEAR OVER TIME AND REQUIRE REPLACEMENT. THIS IS NOT OCCUR INTRA OP AND THEREFORE NO PATIENT ISSUES OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17470576 ↗MalfunctionJul 21, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BLADES ARE WORN DUE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17371102 ↗MalfunctionJun 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DEVICE IS BLUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17200334 ↗MalfunctionJun 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DEVICE IS BLUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17200314 ↗
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
- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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