NA 9400-80-007Recalls & reported problems
Depuy (Ireland) · PROXIMA MI CALCAR REAMER, SMALL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Proxima MI calcar reamer, a small surgical reamer, has 339 reports, with 1 injury and no deaths. The reports mostly describe the reamer failing to cut, going dull, and breaking, and some say instruments needed replacing. 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
- 339
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 10603295223627), received between Apr 11, 2018 and Dec 11, 2025 — classified as 1 injury, 338 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (237 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
- Failure to Cut237
- Dull, Blunt60
- Break34
- Material Twisted/Bent22
- Naturally Worn15
- Material Deformation6
- Adverse Event Without Identified Device or Use Problem2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions245
- No Consequences Or Impact To Patient60
- Insufficient Information27
- No Code Available5
- Not Applicable4
- Bone Fracture(s)1
- No Information1
Recent adverse event reports
The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776112 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776111 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776110 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776109 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776106 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS THAT NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776105 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN KEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771088 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT DURING A HIP SURGERY PROCEDURE, IT WAS OBSERVED THAT THE INSTRUMENT BROKE. THE ADAPTOR WAS GETTING STUCK. THERE WERE NO DELAYS TO SURGERY. NOTHING WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569301 ↗MalfunctionOct 23, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS WORN AND NO LONGER WORKING. THIS OCCURRED DURING HIP SURGERY. IT WAS NOT BROKEN IN HALF (THE CALCAR REAMER IS WORN), NOTHING WAS LEFT IN THE PATIENT, IT DID NOT CAUSE DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369894 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THE METAL FILINGS COMING OFF INSTRUMENT AFTER STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631175 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT HEMI HIP. DURING THE USE OF THE FEMORAL CALCAR REAMER, THE SLEEVE ON THE REAMER CAME OFF ON THE MALE END OF THE BROACH AND WAS LOOSE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456803 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306610 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306608 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306603 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306539 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306519 ↗MalfunctionOct 26, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS DULL, NOT SHARP. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540207 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS DULL, NOT SHARP. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539131 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20538795 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537897 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537524 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT WAS DULL, NOT SHARP. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536659 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536252 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT DURING A HIP SURGERY THE CALCAR REAMER BROKE LOOSE. IT WAS RETRIEVED. AFTER CALCAR BROACHING THEY NOTICE THAT INNER-CENTER SLEEVE OF THE CALCAR REAMER WAS ON THE CORAIL BROACH. THEY TOOK IT UP AND JUST PRESS IT THE CALCAR REAMER AGAIN. THERE WAS NO CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536249 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT CALCAR REAMERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535965 ↗
Other REAMER devices
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- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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.
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