NA 2570-04-500Recalls & reported problems
Depuy (Ireland) · MI INSTRUMENTS MI CALCAR REAMER SHAFT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MI Instruments calcar reamer shaft is a surgical tool used to shape bone during surgery. The 89 reports mostly describe shafts breaking, bending, stripping, or failing to cut and fit with other instruments, with 10 injuries including bone fractures and no deaths. Reports have fallen recently, from 12 in the previous 12 months to 2 in the past year. 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
- 89
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10603295143192), received between Jun 12, 2018 and May 13, 2026 — classified as 10 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (39 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 Incompatibility39
- Failure to Cut20
- Material Twisted/Bent12
- Material Deformation10
- Naturally Worn8
- Break7
- Adverse Event Without Identified Device or Use Problem6
- Scratched Material6
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information14
- No Consequences Or Impact To Patient14
- Bone Fracture(s)10
- No Code Available3
- Not Applicable2
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE PLANAR SHAFT AND STARTER BROACH WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164528 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT BROKEN ITEMS FROM ACTIS CORE TRAY WERE NOTED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO OTHER INFORMATION WAS AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699793 ↗MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN CALCAR REAMING OVER A SIZE 5 ACTIS BROACH THE TRUNION OF THE BROACH SNAPPED OFF WITHIN THE CALCAR MILLER. THE BROACH BECAME STUCK IN THE BONE AND A BURR AND VICE GRIPS WERE NEEDED TO EXTRACT THE BROACH. THIS ADDED ABOUT 20 MINUTES TO SURGERY. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470427 ↗MalfunctionJul 8, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE POINT OF THE MODULAR CALCAR REAMER WAS THREADED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22439813 ↗MalfunctionMar 6, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SHAFT WAS STRIPPED AND WON'T HOLD THE REAMER DISC. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536176 ↗MalfunctionJan 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ATTACHMENT TO POWER WAS BINDING AND DIDN'T CONNECT. THERE IS NO INDICATION THAT THE DELAY OR THE MALFUNCTION RESULTED IN ANY IMPACT TO AN EXPECTED SURGICAL OUTCOME, OR CAUSED ANY PATIENT CONSEQUENCE OR INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21259950 ↗MalfunctionJan 7, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CALCAR PLANAR SHAFT AND BROACH TRUNION COLD WELDED TOGETHER DURING THE CALCAR PLANNING PROCESS. ITEMS WERE SEPARATED AND THE CASE WAS FINISHED WITHOUT FURTHER INCIDENCE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21094133 ↗MalfunctionDec 9, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE CALCAR PLANAR SHAFT THREADS ARE DAMAGED SO THE PLANAR WILL NOT THREAD ON PROPERLY.
Patient problems: Insufficient Information
MAUDE report 20880983 ↗MalfunctionNov 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT CALCAR PLANER SHAFT WAS STRIPPED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20762271 ↗MalfunctionNov 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT CALCAR PLANER SHAFT WAS STRIPPED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20762040 ↗MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THREADING NOT ENGAGING WITH REAMER PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748355 ↗MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THREADING NOT ENGAGING WITH REAMER PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748290 ↗MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PRODUCT PLACED WOULD NOT THREAD ON SHAFT.
Patient problems: Insufficient Information
MAUDE report 20678970 ↗MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PRODUCT PLACED WOULD NOT THREAD ON SHAFT.
Patient problems: Insufficient Information
MAUDE report 20678864 ↗MalfunctionOct 31, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE CALCAR PLANAR SHAFT BROKE AND WOULD NOT ACCEPT THE CALCAR PLANARS.
Patient problems: Insufficient Information
MAUDE report 20580947 ↗MalfunctionOct 31, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE CALCAR PLANAR SHAFT BROKE AND WOULD NOT ACCEPT THE CALCAR PLANARS.
Patient problems: Insufficient Information
MAUDE report 20580929 ↗MalfunctionOct 3, 2024Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANER SHAFT BROKE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20364288 ↗MalfunctionSep 25, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE HEAD CAME LOOSE FROM THE SHAFT DURING SURGERY (POTENTIAL FOR THE CALCAR REAMER TO HAVE BEEN ON REVERSE) AND SURGEON NOTED THAT IT LOOKED LIKE SOMETHING DARK (POTENTIALLY METAL OR SOMETHING NOT NORMAL) WAS ON THE SHAFT OF THE CORAIL BROACH. REMOVED THE ITEMS AND USED THE MILL TO COMPLETE INSTEAD IN THE SET.
Patient problems: Insufficient Information
MAUDE report 20299849 ↗MalfunctionJun 14, 2024Failure to Cut; Failure to Cut
CALCAR REAMERS ARE DULL AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539273 ↗MalfunctionJun 14, 2024Failure to Cut; Failure to Cut
CALCAR REAMERS ARE DULL AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539271 ↗MalfunctionJun 14, 2024Failure to Cut; Failure to Cut
CALCAR REAMERS ARE DULL AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539261 ↗MalfunctionMay 13, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED THAT THE CALCAR PLANER ATTACHMENT IS TOO LONG. THE END OF THE ATTACHMENT STICKS OUT OF THE CALCAR SO THE CALCAR REAMER DOES NOT REACH THE BONE. THIS DID NOT DELAY THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19305098 ↗MalfunctionApr 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER HANDLES AND ATTACHMENTS DO NOT CONNECT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19119240 ↗MalfunctionApr 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER HANDLES AND ATTACHMENTS DO NOT CONNECT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19119233 ↗MalfunctionApr 11, 2024Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION WAS RECEIVED: 1. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS-THREADED, OR ANY DEVICE INTERACTION? BLUNT. NO LONGER FIT FOR PURPOSE. 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY, ANOTHER TRAY IS AVAILABLE, AND A SECOND INSTRUMENT IS USED (FORTUNATELY). 3. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE EVENT OR REACTION TO THE PATIENT. IT WAS ALSO MENTIONED THAT THE CONSIGNMENT INSTRUMENT WILL NEED REPLACING. TAGGED AS DAMAGED TO BE RETURNED AFTER DECONTAMINATION IS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19094001 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- 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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