NA 2421-09-000Recalls & reported problems
Depuy (Ireland) · SHORT "V" OSTEOTOME 7mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295122791), received between Nov 21, 2017 and Apr 20, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient8
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING USE OF THE CEMENT SPLITTER, THE END OF THE SPLITTER BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND DISCARDED IN THE SHARPS BY SURGEON DUE TO BEING SMALL AND SHARP. THE MAIN HANDLE IS BEING RETURNED TO OFFICE TO SHIP BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927169 ↗MalfunctionFeb 25, 2026Break
IT WAS REPORTED THAT MORELAND OSETOTOME WAS BROKEN. STERILE PROCESSING DEPARTMENT CONTACTED AND DEPARTMENT MANAGER CAME TO CONFIRM NO PIECES WERE RETAINED, TOOK BROKEN PIECE TO SPD TO BE CLEANED. WILL KEEP INSTRUMENT IN STERILE PROCESSING DEPARTMENT IF ANY FURTHER INVESTIGATION NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443354 ↗MalfunctionMay 20, 2025Break; Break
IT WAS REPORTED THAT THE V CHISEL ((B)(6)) WAS BROKE DURING SURGERY, V CHISEL ((B)(6)) WAS WORN DOWN AND UN-USEABLE DURING SURGERY AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054430 ↗MalfunctionMay 2, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICES WERE CHIPPED AND CRACKED. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954493 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT THE V SPLITTER TIP WAS IN INSTRUMENTS TRAY, THE TIP WAS BROKEN OFF. INSTRUMENT NOT USED IN SURGERY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515239 ↗MalfunctionJun 21, 2024Break; Break
OSTEOTOME IS BROKE IN HALF ON TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581961 ↗MalfunctionNov 9, 2023Break; Break
IT WAS REPORTED THAT THE END BROKE OFF DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18101818 ↗MalfunctionMar 24, 2023Crack; Crack
IT WAS REPORTED THAT THE WHITE PLASTIC HANDLE CEMENT SPLITTER CRACKED (WHITE HANDLED SHORT V OSTEOTOME).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16609851 ↗MalfunctionDec 21, 2021Break; Break
INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13053748 ↗MalfunctionSep 17, 2021Break; Break
IT WAS REPORTED THAT THE HANDLE IS PEELING, NOTHING WAS LEFT IN THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488477 ↗MalfunctionJun 24, 2021Break; Break
IT WAS REPORTED THAT THE ¿V¿ SHAPED WHITE HANDLE OSTEOTOME SPLIT WHEN BREAKING UP OLD CEMENT ON KNEE RE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063899 ↗MalfunctionJul 7, 2020Break; Break
IT WAS REPORTED THAT THE "SNAKE TOOTH" OSTEOTOME SPLIT AT THE "V" DURING A KNEE REVISION AND BROKE OFF. TIBIAL COMPONENT EXTRACTOR- THE THREADS ON THE HANDLE ATTACHMENT BROKE OFF WHILE THE SURGEON WAS REMOVING A CEMENTED TIBIAL BASE PLATE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10240048 ↗MalfunctionApr 6, 2020Break; Break
THE TWO V-SHAPED OSTEOTOMES IN THE OFFICE MORELAND SET ARE BROKEN AND UNUSABLE. THIS SET WAS DELIVERED THIS WAY AS LOANERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929486 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED THAT (TWO OF THE SAME INSTRUMENTS) THE "V" TIPED MORELAND OSTEOTOME WAS USED TO EXPLANT A FEMUR ON A REVISION KNEE AND WAS BROKEN OFF AT THE TIP ON BOTH INSTRUMENTS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929432 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED THAT (TWO OF THE SAME INSTRUMENTS) THE "V" TIPED MORELAND OSTEOTOME WAS USED TO EXPLANT A FEMUR ON A REVISION KNEE AND WAS BROKEN OFF AT THE TIP ON BOTH INSTRUMENTS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929430 ↗MalfunctionJun 6, 2019Break; Break
IT WAS REPORTED THAT THE METAL END OF INSTRUMENT SHEARED OFF DURING SURGERY AND NEEDS TO BE REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THIS IS A NEW INSTRUMENT AND THE SURGEON FEELS THE PRODUCT WAS DEFECTIVE CONSIDERING IT BROKE IN THE FIRST SURGERY IT WAS USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674936 ↗MalfunctionApr 30, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF INSTRUMENT SHEARED OFF DURING SURGERY AND NEEDS REPLACEMENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND THERE WAS NO DELAY. THIS IS A NEW INSTRUMENT AND THE SURGEON FEELS THE PRODUCT WAS DEFECTIVE CONSIDERING IT BROKE IN FIRST SURGERY IT WAS USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8566570 ↗MalfunctionNov 27, 2017Break; Break
IT WAS REPORTED THAT THE SURGEON BROKE THE INSTRUMENTS WHILE USING THEM TO PROTOCOL. TEMPORARILY USED THE RECEIVED DATE (B)(6) 2017 AS AN EVENT DATE AND ALERT DATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7061364 ↗MalfunctionNov 21, 2017Break; Break
IT WAS REPORTED THAT THE REVISION V-OSTETOME HANDLE BROKE UPON FIRST STRIKE OF USE. SURGEON USED THIS TYPE OF INSTRUMENT BEFORE AND NEVER HAD ONE BREAK. THE ONE PIECE THAT BROKE WAS RETRIEVED IMMEDIATELY FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7051815 ↗
Other OSTEOTOME devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 reports
- 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
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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