NA 2421-02-000Recalls & reported problems
Depuy Orthopaedics, Inc. · FEMORAL/TIBIAL EXTRACTOR 11mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Orthopaedics femoral/tibial extractor is a surgical instrument used to remove knee implant components during surgery. The 34 reports mostly describe the tool breaking or cracking, sometimes snapping in half or chipping, and in a few cases stripped screws or a broken widget leaving pieces that were retrieved; no deaths or injuries were reported. There are no recalls naming this device, and the number of reports is steady (5 in the last 12 months versus 4 in the prior12).
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295122722), received between Jun 22, 2017 and Apr 14, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
- Break27
- Crack4
- Illegible Information2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient10
- No Information5
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT PRODUCT WAS CHIPPED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873137 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT ON UPON OFFICE IN HOUSE INSPECTION, IT WAS FOUND THAT THE INSTRUMENT WAS BROKEN. NO PREVIOUS CASES WERE AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811554 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED THAT INSTRUMENT WAS BROKEN IN HALF, NEED REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119606 ↗MalfunctionNov 5, 2025Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGERY, THE SCREWS ON THE FEMUR IMPACTOR WERE STRIPPED AND WOULD NOT THREAD BACK ON TO THE IMPACTOR, RENDERING IT UNUSABLE FOR SURGERY. ALSO, A WIDGET WAS USED TO HIT OFF THE FEMUR AND A PIECE OF THE WIDGET BROKE OFF. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476697 ↗MalfunctionOct 28, 2025Crack; Crack
IT WAS REPORTED THAT THE REPORTED DEVICES WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401728 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT 2 INSTRUMENTS WAS BROKEN WHILE TRYING TO REMOVE THE FEMORAL COMPONENT. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 22028437 ↗MalfunctionMay 9, 2025Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN WHILE USING TO EXPLANT FEMUR. THERE WAS NO PATIENT HARM AND NO DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996755 ↗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 21954300 ↗MalfunctionJun 28, 2024Break; Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY. ADDITIONAL INFORMATION: THE TIP OF THE DEVICE CHIPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632409 ↗MalfunctionJun 30, 2023Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN DURING EXTRACTION OF KNEE COMPONENTS. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17239187 ↗MalfunctionMar 8, 2023Crack; Crack
IT WAS REPORTED THAT TIP BROKE OFF EXTRACTOR. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504627 ↗MalfunctionFeb 24, 2023Break; Break
THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 242102000. PRODUCT NAME: FEM/TIB EXTRAC 11X7 3/4. QTY: 1. HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 16438484 ↗MalfunctionFeb 20, 2023Break; Break
THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT PRODUCT CODE: 242102000 PRODUCT NAME: FEM/TIB EXTRAC 11X7 3/4 IN LOT NUMBER: SO2058069 QTY: 1 HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES ONE (1) DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403593 ↗MalfunctionAug 25, 2022Break; Break
IT WAS REPORTED THAT THE HANDLE BROKE IN HALF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293619 ↗MalfunctionJul 13, 2022Break; Break
IT WAS REPORTED THAT WHILE ATTEMPTING TO EXTRACT A TOTAL KNEE, THE SURGEON BROKE THE TIPS AND HANDLE OF THE MORELAND OSTEOTOMES. NEW OSTEOTOMES WERE OPENED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADVERSE EVENTS OCCURRED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15000787 ↗MalfunctionJan 5, 2021Break; Break
IT WAS REPORTED THAT A PIECE OF THE WIDGET BROKE OFF WHILE THE SURGEON WAS TRYING TO IMPACT THE FEMUR IMPLANT OFF. THE PIECE THAT BROKE OFF WAS RETRIEVED FROM THE PATIENT SUCCESSFULLY. NO DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118481 ↗MalfunctionDec 22, 2020Break; Break
IT WAS REPORTED THAT THE LITTLE TIP BROKE AT THE END. NOTHING LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057809 ↗MalfunctionDec 22, 2020Break; Break
VOLUNTARY REPORT WAS RECEIVED UNDER MW5097975. IT WAS REPORTED THAT WHILE ATTEMPTING TO HAMMER OUT A FEMORAL IMPLANT DURING AN ORTHOPEDIC SURGICAL PROCEDURE, DISTAL END OF THE OSTEOTOME BROKE OFF, FLEW UP AND STRUCK THE OVERHEAD LIGHT AND LANDED BACK ON THE SURGICAL TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11057574 ↗MalfunctionOct 23, 2020Break; Naturally Worn; Illegible Information; Break; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE HANDLE FRACTURED, ALL FRACTURED PIECES RECOVERED. NOTHING LEFT IN PATIENT AND NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10726534 ↗MalfunctionOct 2, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INTER-CONDL CHISEL WAS CHIPPED AND THE FEMORAL/TIBIAL EXTRACTOR WAS BENT. THESE DID NOT CAUSE DELAY IN SURGERY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10624082 ↗MalfunctionNov 6, 2019Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING SURGERY. CHIPPED OFF THE END.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9284285 ↗MalfunctionJun 21, 2019Break; Break
IT WAS REPORTED THAT THE FEM/TIB EXTRACTOR BROKE DURING CASE. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8723689 ↗MalfunctionJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8236004 ↗MalfunctionAug 14, 2018Crack; Crack
FEM/TIB EXTRACTOR HANDLE CRACKED AND THE TIP OF THE INSTRUMENT BROKE OFF WHILE REMOVING A FEMORAL COMPONENT. ALL PIECES WERE RETRIEVED AND THERE WAS NO ADDITIONAL TIME ADDED TO THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7781320 ↗MalfunctionMar 27, 2018Break; Break
IT WAS REPORTED THAT THE IMPACTOR HANDLE BROKE. ALL PIECES REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372991 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 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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