SIGMA 2024-47-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295083191), received between Jul 24, 2017 and Sep 22, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Break” (35 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that Metal part broke away from the plastic handle, 3x7mm green spacer snapped in two during removal after trialing. Couple of breakages of instruments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852980 ↗
• MalfunctionSep 15, 2026Break; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777547 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ITEMS WERE DAMAGED. ISSUES DID NOT OCCUR DURING SURGERY. SIGMA HP UNI TIB CUT BLK LM/RL (X2) ¿ CUTTING SLOT DAMAGED, BLADE HAS HIT IT AND NOW UNABLE TO PUT SAW BLADE THROUGH HOLE EASILY. 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. SIGMA HP UNI ANTERIOR CHISEL ¿ CHISEL END SNAPPED INTO TWO PIECES, PIECES BOTH DISPOSED OF. SIGMA HP UNI AP KEEL OSTEOTOME ¿ METAL KEEL END BENT, NO LONGER FIT FOR USE. SIGMA HP UNI FB KEEL OSTEOTOME - METAL KEEL END BENT, NO LONGER FIT FOR USE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018345 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT JAMMED MODULAR REAMERS HANDLE BROKE DURING A KNEE OSTEOTOME.

  Patient problems: Insufficient Information

  MAUDE report 21585609 ↗
• 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 20824779 ↗
• MalfunctionAug 27, 2024Break; Break

  WHEN USING THE TIBIAL OSTEOTOME TO REMOVE THE BONE FROM THE KEEL SLOT, THE METAL BUTTON AT THE END OF THE OSTEOTOME CAME LOOSE BECAUSE OF A HAMMER BLOW. WHEN REMOVING THE OSTEOTOME THE WHOLE INSTRUMENT FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074712 ↗
• 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 18778545 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT HANDLE CAME APART DURING SURGERY-ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731229 ↗
• MalfunctionDec 11, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE HANDLE DID BREAK INTO 4 PIECES. ALL PIECES ARE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301825 ↗
• MalfunctionNov 30, 2023Break; Break

  PRIOR TO USE, SCRUB PRACTITIONER NOTICED THE END OF METAL BACKED SCRAPER WAS BROKEN OFF. OSTEOTOME WAS NOT USED ON PATIENT, ALTERNATIVE SOURCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238722 ↗
• MalfunctionDec 21, 2022Break; Break

  IT WAS REPORTED THAT THE METAL BACKED GOUGE BROKE DURING DECONTAMINATION PROCESS AFTER THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT AND SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023152 ↗
• MalfunctionDec 5, 2022Break; Break

  IT WAS REPORTED THAT WHILE PUTTING SIGMA UNI INSTRUMENTS BACK TOGETHER AFTER YESTERDAY CASE, IT WAS NOTICED THAT THE END CAP ON METAL BACK RED OSTEOTOME HANDLE WAS BROKEN SO THE SHAFT WAS FREE TO SLIDE OUT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915938 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THAT PLASTIC HANDLE CAME OFF OF KEEL OSTEOTOME. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837913 ↗
• 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 15536633 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED INSTRUMENT 20248500 BROKE INTO TWO PIECES WHEN SURGEON STRUCK IT WITH MALLET. IT WAS REPORTED THE INSTRUMENT 202447111 SNAPPED WHILE PREPARING THE TIBIA. SURGICAL DELAY OF 5 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232406 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THE BACK OF THE METAL BACKED KEEL PUNCH HAD BROKEN OFF, CAUSING THE HANDLE TO BREAK AWAY FROM THE METAL PART OF THE INSTRUMENT. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193041 ↗
• MalfunctionMay 13, 2022Break; Break

  IT WAS REPORTED THAT THE HANDLE FROM THEIR CURVED OSTEOTOME HAD SNAPPED INTO TWO PIECES. NO PIECES WERE LEFT IN THE PATIENT AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399914 ↗
• MalfunctionDec 6, 2021Break; Break

  IT WAS REPORTED THAT THE HANDLE CAME APART IN TWO PIECES . OPERATION COMPLETED SUCCESSFULLY. NO PATIENT IMPACT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935069 ↗
• MalfunctionSep 23, 2021Break; Break

  NOTICE THE METAL BACK KEEL CUTTING HANDLE THAT WAS SHIPPED FROM AN OFFICE SET WAS BROKEN. THE METAL CAP ON THE HANDLE WAS MISSING. THE METAL CAP WAS NOT IN THE TRAY OF INSTRUMENTS. IT WAS NOT USED DURING THE SURGERY. THE HANDLE IS BEING SHIP TO THE RETURNS DEPT AT DEPUY (B)(6) ADDRESS. NO DELAY IN SURGERY. DID THE EVENT OCCUR DURING STERILE PROCESSING? YES, DID THE EVENT OCCUR DURING FIELD INSPECTION? YES, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OF SALES CONSULTANT. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519830 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT THE OSTEOTOME PLASTIC HANDLE BROKE OFF DURING SURGERY, ONE PIECE. IT WAS DISCARDED BY O.R. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996331 ↗
• MalfunctionApr 13, 2021Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  UPON INSPECTION OF THE HANDLE, I NOTICE THE METAL KEEL AND THE INNER ROD WERE LOOSE. REQUESTED A REPLACEMENT. WILL BE SHIPPING THIS WORN OUT ONE TO APPROPRIATE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656348 ↗
• MalfunctionJan 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGEON PREPARED TIBIA WITH METAL BACKED OSTEOTOME FROM SIGMA PARTIAL KIT AND THE END CAP FELL OFF. NO DELAY IN SURGERY, TOOL STILL WORKED AND SURGEON SUCCESSFULLY WAS ABLE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11225298 ↗
• MalfunctionDec 18, 2020Break; Break

  IMPACTING HEAD OF 202447111 OSTEOTOME HAS BROKEN OFF. IMPACTING HEAD NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11040908 ↗
• MalfunctionMay 7, 2020Break; Break

  IMPACTING HEAD OF 202447111 SIGMA HP UNI FB KEEL OSTEOTOME HAS BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032325 ↗
• MalfunctionMar 31, 2020Break; Break

  IT WAS REPORTED THAT THE SIGMA PARTIAL UNI TIBIAL KEEL OSTEOTOME WAS SENT TO THE HOSPITAL BROKEN. IT WAS SEPARATED INTO TWO SEPARATE PIECES. THE RED HANDLE AND THE KEEL OSTEOTOME SHAFT WERE SEPARATED WHEN THE INSTRUMENT TRAY WAS OPENED IN THE THEATRE, SO NOTHING BROKE INSIDE THE PATIENT AND NO FRAGMENTS WERE GENERATED. THE OPERATION WAS COMPLETED USING THE SAME INSTRUMENT AS THERE WAS NO ALTERNATIVE INSTRUMENT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9907920 ↗