SIGMA 2024-85-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295084020), received between Sep 22, 2017 and Feb 4, 2026 — classified as 1 injury, 62 malfunctions.

The most frequently reported specific device problem is “Break” (52 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT THE CHISEL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257533 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT CHISEL BROKE DURING SURGERY. NO ADVERSE PATIENT EVENT, ALL PIECES WERE RETRIEVED. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880327 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2025, THE CHISEL SNAPPED. THE PROCEDURE WAS COMPLETED WITH NO DELAY OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939002 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE CHISEL HAS SNAPPED. THE ITEM WAS REMOVED FROM THE SET. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631127 ↗
• MalfunctionMay 14, 2025Break; Break

  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 22018339 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT A CHISEL BROKE IN HALF. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934391 ↗
• MalfunctionMar 4, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. AFTER ALL THE FEMORAL PREP WAS DONE, CHISEL PREP COMMENCED. WHEN IMPACTING OUT, THE CHISEL GOT STUCK AND SNAPPED INSIDE THE FEMORAL CUTTING BLOCK. THE BROACH CORAIL AMT 12 WAS BROKEN. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517791 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDER TOTAL KNEE REPLACEMENT ON NOVEMBER 6, 2024. A CHISEL SNAPPED WHILE IN USE. ALL FRAGMENTS WERE EASILY REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20707346 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE ANTERIOR CHISEL WAS USED A SMALL FRACTURE APPEARED IN THE TROCHLEA JUST ABOVE. THIS AFFECTED PATELLA TRACKING SO A TOTAL KNEE REPLACEMENT WAS REQUIRED. CASE CHANGED FROM A UNI KNEE TO A TOTAL KNEE REPLACEMENT. SURGERY WAS PROLONGED BY 15 MINUTES DUE TO THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 20372631 ↗
• MalfunctionOct 2, 2024Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE OSTEOTOME WAS BENT, THEREFORE IT DOES NOT FIT THROUGH THE JIG. THE CASE PROCEEDED, BUT CAUSED THE ITEM TO BECOME DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY WAS PROLONGED BY TWO MINUTES DUE TO THE EVENT. THE CHISEL WAS BROKEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353404 ↗
• MalfunctionSep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  WHEN USING THE ANTERIOR CHISEL, IT BROKE IN HALF. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130344 ↗
• MalfunctionJul 10, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE OSTEOTOME IS BENT, THEREFORE IT DOES NOT FIT THROUGH THE JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709141 ↗
• MalfunctionJun 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PUNCH THAT GOES THROUGH CUTTING BLOCKS GETS STUCK IN TWO OF THE BLOCKS. NO PIECES BROKE OFF, JUST GETS STUCK WHEN YOU INSERT THE PUNCH IN THE CUTTING BLOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19503432 ↗
• MalfunctionApr 20, 2024Break; Mechanical Jam; Break; Mechanical Jam

  WHILE SURGEON WAS USING THE ANTERIOR CHISEL, IT GOT STUCK ON THE CUTTING BLOCK AND BROKE IN (B)(4) PIECES. BOTH PIECES RETRIEVED AND NO HARM TO PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149702 ↗
• MalfunctionFeb 7, 2024Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE CHISEL BROKE. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO; DID THE EVENT HAPPEN DURING A PROCEDURE? NO; WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO; EVENT OUTCOME/HOW WAS IT MANAGED? N/A; 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: 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: IT BROKE LIKE MANY OF THEM DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658274 ↗
• MalfunctionJan 11, 2024Break; Material Deformation; Naturally Worn; Break; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING END IS BENT AND UNABLE TO BE USED THROUGH THE FEMORAL CUTTING SLOT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> 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 -->NONE, DEVICE IN POSSESSION OF -->NONE 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 18491362 ↗
• MalfunctionDec 18, 2023Material Deformation; Material Deformation

  THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGES PFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGE SP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKEN SIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGE SIGMA HP UNI ANTERIOR CHISEL WERE BENT PFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPED THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347262 ↗
• MalfunctionDec 18, 2023Material Deformation; Material Deformation

  THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGESPFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGESP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKENSIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGESIGMA HP UNI ANTERIOR CHISEL WERE BENTPFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPEDTHERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346295 ↗
• MalfunctionDec 18, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT NO ADVERSE AFFECTS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18345542 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BY SSP TO BE WORN. WONT FIT IN THE CUT BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290120 ↗
• MalfunctionDec 4, 2023Break; Break

  ITEM BROKEN INTO TWO PIECES THROUGH THE LONG END OF THE CHISEL. BOTH PIECES REMOVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260191 ↗
• MalfunctionNov 30, 2023Break; Naturally Worn; Break; Naturally Worn

  CHISEL BROKE IN HALF, LIKELY DUE TO WEAR AND TEAR AS IT IS AN OLD KIT. THERE WERE NO ADVERSE EFFECTS ON THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238265 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT THE CHISEL GOT BROKEN UPON TRYING TO SLIDE IT OFF THE CUTTING BLOCK. BROKEN IN TWO PIECES. ALL BROKEN PIECES REMOVED. SURGEON STILL MANAGED TO SLOT THE CHISEL IN THE CUTTING BLOCK AND THEN IT GOT STOCKED AND BROKEN IN 2 PIECES WHILE TRYING TO SLIDE IT OUT THE CUTTING BLOCK. SURGEON MANAGED TO GET ALL BROKEN PIECES AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118064 ↗
• MalfunctionAug 28, 2023Material Deformation; Material Deformation

  CSSD HEALTHCARE PROFESSIONAL IDENTIFIED DAMAGE TO THE LOAN SIGMA PARTIAL CHISEL. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633390 ↗
• MalfunctionAug 15, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ANTERIOR CHISEL BROKE AND GOT STUCK IN THE CUTTING BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548260 ↗