SIGMA 2024-46-010Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE ALL POLY TIB KEEL OSTEOTOME · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295083160), received between Aug 17, 2017 and Aug 7, 2025 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break15
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
- No Information2
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RED HANDLED KEEL OSTEOTOME WAS BROKEN. VERSION STICK BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737925 ↗MalfunctionMay 14, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. B. PLEASE VERIFY IF THERE WAS ANY ADVERSE EVENT/PATIENT HARM INVOLVED? THIS DID NOT HAPPEN DURING THE PROCEDURE SO NOT APPLICABLE. C. WHAT DO YOU MEAN BY DAMAGED FOR THE PRODUCT CODES: 202440100 AND 202440200? 202440100 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440100 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK LM/RL ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL 202440200 - (B)(4) / (B)(6) - SIGMA HP UNI TIB CUT BLK RM/LL - CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY ¿ IN ONE PIECE STILL ALL ITEMS ABOVE HAVE A CUTTING SLOT ¿ WHERE THE SAW BLADE HAS REPEATEDLY HIT THIS DURING SURGERY IT HAD WARPED THE METAL CAUSING DAMAGE AND THE SAW BLADE NO LONGER CAN FIT THROUGH THE CUTTING SLOT. ALL ITEMS ARE STILL IN ONE PIECE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22018349 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT THE METAL BACK AND ALL POLY GOUGE BROKE. LM AND RM TIBIA CUT GUIDES ARE BENT.
Patient problems: Insufficient Information
MAUDE report 20824741 ↗MalfunctionFeb 26, 2024Break; Break
SURGEON WAS PREPPING THE TIBIAL WITH THE FB KEEL AND AS HE SAID THE BONE WAS VERY HARD THAT THE INSTRUMENT SNAPPED AT THE TIP (WHERE THE KEEL IS). NO PATIENT HARM, NO DELAYS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778540 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT THE T5 RM/LL AND LM/RL FEMUR IMPLANTS WERE MISSING. THE TIBIAL OSTEOTOME IS USED DURING THE PREPARATION OF THE TIBIAL SIGMA BASE, I.E. AT THE END OF THE OPERATION. TIBIAL OSTEOPOROSIS ALL POLY BROKE DURING THE INTERVENTION. THE INTERVENTION WAS ABLE TO TAKE PLACE NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860142 ↗MalfunctionJun 22, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT LOCKING CAP WAS BROKEN OFF ONE END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183888 ↗MalfunctionOct 4, 2022Break; Break
IT WAS REPORTED THAT THE END CAP HAS BROKEN OFF KEEL OSTEOTOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536634 ↗MalfunctionFeb 27, 2020Break; Break
IMPACTING HEAD OF THE 202446010 OSTEOTOME HAS BROKEN OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9763765 ↗MalfunctionJan 19, 2020Break; Break
IT WAS REPORTED THAT BOTH GOUGES BROKE AT THE BACK OF THE HANDLE. BOTH WERE BROKEN DURING STERILIZATION, NOT DURING SURGERY. NEEDS REPLACEMENT BOTH P1 TO DUKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9604991 ↗MalfunctionJan 9, 2019Break; Break
IT WAS REPORTED THAT ALL POLYOSTEOTOME WAS FOUND BROKEN UPON CLEANING UP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8230959 ↗MalfunctionJan 7, 2019Break; Break
IT WAS REPORTED THAT AS THE SURGEON WAS USING THE ALL POLY GAUGE FOR THE TIBIA, THE SILVER GOUGE PIECE BROKE OFF INTO ONE PIECE. THE PIECE WAS RETRIEVED FROM THE PATIENT, BUT WAS THROWN OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8221931 ↗MalfunctionOct 24, 2018Break; Break
MalfunctionAug 13, 2018Break; Break
IMPACTING HEAD OF OSTEOTOME HAS BROKEN OFF. IMPACTING HEAD WAS NOT RETURNED. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7776819 ↗MalfunctionJul 2, 2018Break; Break
IT WAS REPORTED THAT THE TIP BROKE OFF OF THE ALL POLY KEEL OSTEOTOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7654267 ↗MalfunctionJun 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE KEEL OSTEOTOME HAD BEEN LEFT/CLOGGED IN THE LOOPED SECTION OF THE DEVICE AFTER CLEANING/STERILIZATION WHICH RESULTED IN A NEW KIT HAVING TO BE OPENED AND A REPLACEMENT DEVICE HAVING TO BE SUBSTITUTED IN. WAS UNAWARE OF WHAT THE INSTRUMENT WAS OR LOOKED LIKE THE REP SHOWED ME AN IMAGE FROM A SURGICAL TECHNIQUE AND POINT TO THE AREA IN WHICH SHE HAS SEEN BONE COLLECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7573544 ↗MalfunctionNov 17, 2017Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS BROKEN INTO THREE PIECES.
Patient problems: No Information
MAUDE report 7041607 ↗MalfunctionAug 17, 2017Break; Break
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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