NA 2421-01-000Recalls & reported problems
Depuy (Ireland) · INTER-CONDYLAR FEMORAL CHISEL 8mm x 10mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy inter-condylar femoral chisel is a manual surgical chisel. The 40 reports mostly describe it breaking, cracking, chipping, or deforming during use, sometimes with pieces retrieved, but no deaths or injuries. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295122715), received between Oct 20, 2017 and Dec 29, 2025 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (30 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
- Break30
- Crack4
- Dull, Blunt3
- Material Deformation2
- Material Twisted/Bent2
- Device Damaged Prior to Use1
- Fracture1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient15
- Insufficient Information2
- No Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENT IS CHIPPED, NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908220 ↗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 22028411 ↗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 21954309 ↗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 21954295 ↗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 21954214 ↗MalfunctionJul 12, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT TIP BROKE OFF. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19728500 ↗MalfunctionFeb 5, 2024Break; Break
IT WAS REPORTED THAT THE ITEM HANDLE WAS FOUND BROKEN AFTER WASH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18638937 ↗MalfunctionJan 4, 2024Break; Break
IT WAS REPORTED THAT THE CHISEL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444146 ↗MalfunctionJul 17, 2023Break; Break
IT WAS REPORTED THAT AS THE SURGEON WAS TRYING TO USE THE CHISEL TO REMOVE THE FEMUR, THE TIP OF CHISEL BROKE INTO TWO PIECES. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333542 ↗MalfunctionDec 28, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT A NEW CHISEL WAS RECEIVED THAT WAS DAMAGED OUT OF THE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16061768 ↗MalfunctionJun 21, 2022Break; Break
IT WAS REPORTED THAT THE CHISEL HAS BECOME CHIPPED AND NOW HAS SHARP EDGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14759481 ↗MalfunctionMay 31, 2022Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT A BRAND NEW INTER-CONDYLAR CHISEL 2421-01-000. USED FOR THE FIRST TIME ON (B)(6) 2022 ON A REVISION KNEE. CHIPS HAVE BEEN TAKEN OUT OF THE CHISEL. DOCTOR AWARE AND NOT CONCERNED AND PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14549139 ↗MalfunctionNov 16, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12823640 ↗MalfunctionNov 10, 2021Crack; Crack
IT WAS REPORTED THAT THE CEMENT CHISEL CRACKED, ALL PIECES RETRIEVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12786908 ↗MalfunctionOct 21, 2021Break; Break
IT WAS REPORTED THAT THE SHOVEL OSTEOTOME CONSIGNED AT KSSE CHIPPED 242101000.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12674705 ↗MalfunctionJun 7, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE STARTER OSTEOTOMES HAVE CHIPPED AND WORN OUT OVER REPEATED USE. THEY NO LONGER HAVE THE SAME LENGTH TO START TO BREAK UP THE CEMENT IMPLANT INTERFACE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11948238 ↗MalfunctionJun 7, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE STARTER OSTEOTOMES HAVE CHIPPED AND WORN OUT OVER REPEATED USE. THEY NO LONGER HAVE THE SAME LENGTH TO START TO BREAK UP THE CEMENT IMPLANT INTERFACE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11948232 ↗MalfunctionMay 13, 2021Break; Break
IT WAS REPORTED THAT THE REVISION HANDLE TIP BROKE DURING SURGERY. SURGERY NOT DELAYED. PATIENT NOT AFFECTED. ALL PIECES REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11820095 ↗MalfunctionMar 3, 2021Break; Break
IT WAS REPORTED THAT THE MORELAND TAMP AND OFFSET HANDLE WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11407870 ↗MalfunctionOct 22, 2020Break; Break
CHIPPED FLAT OSTEOTOME AND CHISEL. BOTH CHIPPED INTO MULTIPLE PIECES FROM TIP, ALL PIECES WERE RETRIEVED. NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10718464 ↗MalfunctionOct 2, 2020Break; Break
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 10624079 ↗MalfunctionOct 7, 2019Break; Break
IT WAS REPORTED THAT THE END OF THE OSTEOTOMES ARE BEAT UP. NEEDS REPLACEMENT, SURGERY WAS NOT DELAYED AND NOTHING WAS LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9161808 ↗MalfunctionMar 19, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TIPS OF THE INSTRUMENTS WERE WORN AND NEED REPLACING. THERE WERE NO BROKEN PARTS, NO BROKEN PIECES AND NO INSTRUMENTS LEFT IN THE PATIENT. EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. ADDITIONALLY, THE TIP OF THE DEVICE WAS IDENTIFIED AS CHIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8432349 ↗MalfunctionMar 11, 2019Break; Dull, Blunt; Break; Dull, Blunt
IT WAS REPORTED THAT THE TIP IS DULL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8407439 ↗MalfunctionFeb 19, 2019Break; Break
IT WAS REPORTED THAT THE OFFSET OSTEOTOME BROKE OFF DURING REMOVAL OF TIBIAL INSERT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8349938 ↗
Other CHISEL, SURGICAL, MANUAL devices
- SIGMA 2024-85-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL63 reports
- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 reports
- GENESIS II 71440144Smith & Nephew, Inc. · CHISEL, SURGICAL, MANUAL3 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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