NA 2598-07-530Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS MODULAR BOX OSTEOTOME · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Modular Box Osteotome is a surgical chisel used to cut and shape bone. The 89 reports mostly describe instruments bending, breaking, or going dull so they no longer cut properly. There are no deaths, no injuries, and 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
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295148517), received between Jun 19, 2018 and Sep 18, 2026 — classified as 86 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (36 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 Cut36
- Material Deformation27
- Break21
- Device-Device Incompatibility11
- Dull, Blunt6
- Naturally Worn5
- Material Twisted/Bent2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Insufficient Information15
- No Consequences Or Impact To Patient8
- Not Applicable4
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830546 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794792 ↗MalfunctionJun 12, 2026Material Deformation
IT WAS REPORTED THAT THE CONSIGNMENT TRAY HAD A DAMAGED MODULAR BOX OSTEOTOME. IT WAS BENT AT THE END. OPENED ANOTHER TRAY FOR DOCTOR'S HIP CASE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491121 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THAT THE BLADE OF THE MODULAR BOX OSTEOTOME DEVICE WAS BENT. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348732 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED THAT BOX OSTEOTOME BECAME BLUNTED AND BENT AFTER USE. NO BROKEN INSTRUMENTS, NO DELAY, NO ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162181 ↗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 24699726 ↗MalfunctionNov 12, 2025Break; Break
IT WAS REPORTED THAT CHIPPED BOX OSTEOTOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536400 ↗MalfunctionJul 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE STRAIGHT BROACH HANDLE DID NOT CLOSE PROPERLY AND THE MODULAR BOX OSTEOTOME WAS DULL AND THE EDGES WERE ROLLED. ITEMS WERE DISCARDED AS THEY WERE UNFIT FOR USE ON A PATIENT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555650 ↗MalfunctionJul 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE STRAIGHT BROACH HANDLE DID NOT CLOSE PROPERLY AND THE MODULAR BOX OSTEOTOME WAS DULL AND THE EDGES WERE ROLLED. ITEMS WERE DISCARDED AS THEY WERE UNFIT FOR USE ON A PATIENT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555468 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE OSTEOTOME WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175122 ↗MalfunctionApr 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ACTIS BOX OSTEOTOME STRIPPED AND WOULD NOT CONNECT TO BROACH HANDLE. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21900717 ↗MalfunctionApr 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ACTIS BOX OSTEOTOME STRIPPED AND WOULD NOT CONNECT TO BROACH HANDLE. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21900689 ↗MalfunctionMar 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOX OSTEOTOME POST BROKE AND WOULDN'T ATTACH TO BROACH HANDLE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21677674 ↗MalfunctionMar 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOX OSTEOTOME POST BROKE AND WOULDN'T ATTACH TO BROACH HANDLE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21677672 ↗MalfunctionMar 11, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE INSTRUMENT WAS BENT.
Patient problems: Insufficient Information
MAUDE report 21575362 ↗MalfunctionMar 11, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE INSTRUMENT WAS BENT.
Patient problems: Insufficient Information
MAUDE report 21575361 ↗MalfunctionFeb 7, 2025Break; Break
IT WAS REPORTED THAT STARTER BROACH WAS USED EVERY CASE AND HAS BECOME WORN. THE BOX OSTEOTOME IS HAS A SMALL CHIP OR MARK ON IT.
Patient problems: Insufficient Information
MAUDE report 21335365 ↗MalfunctionFeb 6, 2025Break; Break
IT WAS REPORTED THAT STARTER BROACH IS USED EVERY CASE AND HAS BECOME WARNED. THE BOX OSTEOTOME HAS A SMALL CHIP OR MARK ON IT. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21322586 ↗MalfunctionJan 24, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEONS REQUESTED SHARPER BOX CUTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232735 ↗MalfunctionJan 24, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEONS REQUESTED SHARPER BOX CUTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232732 ↗MalfunctionJan 24, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEONS REQUESTED SHARPER BOX CUTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232722 ↗MalfunctionJan 24, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEONS REQUESTED SHARPER BOX CUTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232715 ↗MalfunctionOct 17, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE MODULAR BOX OSTEOTOME IS DULL AND NEEDS REPLACED. NO HARM TO PATIENT AND NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470581 ↗MalfunctionOct 16, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT ACTIS BOX OSTEOTOME WAS EXTREMELY DULL AND STRIPPED ON ONE OF THE SIDES.
Patient problems: Insufficient Information
MAUDE report 20462057 ↗MalfunctionOct 3, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 4/5 STD NECK SEGMENT WILL NO LONGER FIT ON BROACHES BOX OSTEOTOME. THE TIP WAS BENT.
Patient problems: Insufficient Information
MAUDE report 20359251 ↗
Other OSTEOTOME devices
- NA 2002-31-000Depuy (Ireland) · OSTEOTOME61 reports
- Watson Extraction System 17601Depuy (Ireland) · Osteotome60 reports
- MORELAND 2422-10-000Depuy Orthopaedics, Inc. · OSTEOTOME53 reports
- SIGMA 2024-47-111Depuy (Ireland) · OSTEOTOME43 reports
- Watson Extraction System 17001Depuy (Ireland) · Osteotome41 reports
- CS-PLUS/CSL-PLUS 75002165Smith & Nephew, Inc. · OSTEOTOME35 reports
- NA 2002-25-000Depuy (Ireland) · OSTEOTOME31 reports
- Watson Extraction System 17201Depuy (Ireland) · Osteotome21 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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