MORELAND 2422-10-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MORELAND REV INST THIN OSTEOTOME HANDLE · Class 1
All models of MORELAND (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Moreland flexible osteotome handle is a surgical instrument handle used in joint replacement procedures. Most of the 53 reports describe the handle or its locking screw breaking or snapping during use, sometimes cracking or coming apart where the blade is inserted, with a few mentioning worn or bent parts and mismatched equipment. No deaths or injuries are reported, and many reports note no effect on the patient. There are no recalls naming 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295123071), received between Sep 8, 2017 and Mar 6, 2026 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Break” (40 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
- Break40
- Device-Device Incompatibility9
- Naturally Worn4
- Material Deformation3
- Material Twisted/Bent3
- Appropriate Device Problem Term/Code Not Available2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient22
- Insufficient Information3
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT SCREW THAT LOCKS DOWN BLADES IN THE MORELAND FLEXIBLE OSTEOTOME HANDLE SHEARED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532298 ↗MalfunctionJan 7, 2026Break
IT WAS REPORTED THAT LOCKING SCREW FROM FLEXIBLE OSTEOTOME HANDLE BROKE. THE SET SCREW THAT HOLDS THE BLADE BROKE IN 2 PIECES. NO FRAGMENTS GENERATED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23994043 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT OSTEOTOME HANDLE BROKE. SCREW BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963813 ↗MalfunctionMar 17, 2025Break; Break
IT WAS REPORTED THAT TIBIA EXTRACTOR BROKE WHILE REMOVING THE TIBIA. THE FEMORAL EXTRACTOR WON¿T GRIP SIDES OF FEMUR ANYMORE. THE CLAWS WERE WORN DOWN. OSTETOME HANDLE BROKE APART WHERE BLADE IS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620741 ↗MalfunctionMar 17, 2025Break; Break
IT WAS REPORTED THAT TIBIA EXTRACTOR BROKE WHILE REMOVING THE TIBIA DURING A TOTAL KNEE REPLACEMENT. FEMORAL EXTRACTOR WON¿T GRIP SIDES OF FEMUR ANYMORE AS THE CLAWS ARE WORN DOWN. OSTEOTOME HANDLE BROKE APART WHERE BLADE IS INSERTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620210 ↗MalfunctionFeb 20, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422010 ↗MalfunctionJan 31, 2025Crack; Crack
IT WAS REPORTED THAT HOSPITAL SHOWED SALES REP THINS HANDLE HAS A CRACK IN HANDLE
Patient problems: Insufficient Information
MAUDE report 21283323 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED DURING A TOTAL HIP PROCEDURE ON (B)(6) 2024 THE SCREW IN THE INSTRUMENT HAS BROKEN OFF DURING USE. NO PATIENT CONSEQUENCE. NO KNOWN SURGICAL DELAY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685942 ↗MalfunctionOct 15, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS A BROKEN AND WORN PINNACLE 32MM +4/10 DEGREE LINER TRIAL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451963 ↗MalfunctionSep 30, 2024Break; Break
IT WAS REPORTED THAT (B)(6) 2024, THE CORAIL EXTRACTION OSTEOTOME HANDLE SCREW BROKE IN HANDLE DURING USE. THE FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333286 ↗MalfunctionSep 4, 2024Break; Break
IT WAS REPORTED THAT THE SCREW THREAD SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139535 ↗MalfunctionJul 23, 2024Break; Break
IT WAS REPORTED THAT SCREW BROKE, ALL PIECES WERE FOUND AND THERE WAS NO DELAYS IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805067 ↗MalfunctionApr 9, 2024Break; Break
IT WAS REPORTED THAT THE OSTEOTOME HANDLE BROKE. THIS OCCURRED DURING SURGERY AND NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070312 ↗MalfunctionMar 15, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREAD HAS WORN AND WOULDN¿T TIGHTEN THE OSTEOTOME INTO PLACE. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? NA. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: YES. NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT. THE THREAD HAS WORN AND WOULDN¿T TIGHTEN THE OSTEOTOME INTO PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18912994 ↗MalfunctionSep 22, 2023Break; Break
IT WAS REPORTED THAT DEVICE BROKE DURING USE. SURGICAL TIME WAS NOT PROLONGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17799384 ↗MalfunctionSep 7, 2023Break; Break
IT WAS REPORTED THAT THE OSTEOTOME HANDLE WAS BROKEN UPON RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17700259 ↗MalfunctionMar 28, 2023Break; Structural Problem; Break; Structural Problem
IT WAS REPORTED THAT THE LOCKING SCREW TO HOLD THE OSTEOTOME IN PLACE AS BECOME INEFFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16626905 ↗MalfunctionNov 29, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE DOESN¿T HOLD THE OSTEOTOME BLADES SECURELY, LOCKING MECHANISM IS LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15878501 ↗MalfunctionMar 24, 2022Break; Break
THE HANDLE HOLDING A FLEXIBLE OSTEOTOME BROKE DURING SURGICAL PROCEDURE. THE SURGEON WAS ABLE TO COMPLETE THE CASE USING AN ALTERNATE OSTEOTOME AND HANDLE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892835 ↗MalfunctionMar 15, 2022Break; Break
IT WAS REPORTED THAT WHEN USING THE FLEXIBLE OSTEOTOMES THE BOLT THAT SECURES THE BLADE TO HANDLE BROKE AND HANDLE CAME APART. SURGICAL DELAY OF 30 MINUTES.
Patient problems: Insufficient Information
MAUDE report 13770188 ↗MalfunctionFeb 4, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON THE FLEXIBLE OSTEOTOME HANDLE - SCREW HAD SEIZED IN PLACE. DID NOT HOLD OSTEOTOME WELL.
Patient problems: Insufficient Information
MAUDE report 13452989 ↗MalfunctionSep 15, 2021Break; Break
COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE TIBIA WITH THE FLEXIBLE OSTEOTOME, THE HANDLE BROKE AFTER MULTIPLE HITS FROM THE MALLET. THE SCREW THAT HOLDS THE OSTEOTOME ON BROKE. THIS DID NOT SLOW DOWN THE SURGERY AND NO PARTS WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12476123 ↗MalfunctionSep 14, 2021Break; Break
IT WAS REPORTED THAT THE SET SCREW HAS BROKEN OFF. INSTRUMENT IS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12467506 ↗MalfunctionJul 22, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS TAGGED AS DAMAGED WITH A BROKEN OSTEOTOME HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12214703 ↗MalfunctionApr 16, 2021Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN OSTEOTOME HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11678560 ↗
Other OSTEOTOME devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 reports
- NA 2002-31-000Depuy (Ireland) · OSTEOTOME61 reports
- Watson Extraction System 17601Depuy (Ireland) · Osteotome60 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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