SPECIALIST 96-6144Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295246992), received between Dec 15, 2017 and Nov 30, 2023 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Break; Break

  DAMAGED SIGMA SZ4 CHAMFER BLOCK, THE SMALL KNOB ON TOP OF CUTTING SLOT GUIDE HAS BROKEN OFF. ALL PIECES RETRIEVED. NO DELAY TO SURGERY OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237257 ↗
• MalfunctionOct 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE TKR, THE SIZE 4 CUTTING BLOCK FELL APART. THIS IS A POP UP CUTTING BLACK PART OF THE SP2 RANGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572099 ↗
• MalfunctionAug 5, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SIGMA 4 IN 1 CUT BLOCK WAS LOCKING UP IN THE ANTERIOR CHAMFER CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175055 ↗
• MalfunctionJun 23, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLOTS BURRED. NO PATIENT CONSEQUENCES, DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788771 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT THE PFC SIZE 4 CHAMFER CUTTING BLOCK IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950749 ↗
• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 4 CUT BLOCK WAS BENT AND WOULD NOT PASS THROUGH A SAW BLADE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933642 ↗
• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 4 CUT BLOCK WAS BENT AND WOULD NOT PASS THROUGH A SAW BLADE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933638 ↗
• MalfunctionSep 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 4 4IN1 CUT BLOCK WAS BINDING DURING HIS CUTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533829 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SIZE 4 CUT BLOCK POSTERIOR CUT THROUGH IS BENT. NO PIECES WERE BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525922 ↗
• MalfunctionAug 11, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT HAS WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306646 ↗
• MalfunctionFeb 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON 1/04/21 DURING A CASE, IT WAS NOTICED THAT THE SIGMA SPECIALIST 2, TIBIAL DRILL SIZE 4-6 WAS DULL. THE DRILL WAS NOT DAMAGED IN ANY WAY AND NO PIECES ARE MISSING FROM THE DRILL. THE DRILL IS RETRIEVED AND BEING SENT ON THE LOOP ((B)(6) 2021). IN THE SAME CASE ON (B)(6) 2021, THE SIGMA SPECIALIST 2, SIZE 4, 4-1 CUTTING BLOCK IS DAMAGED ON THE CUTTING SLOTS, MAKING IT HARD TO GET THE SAW BLADE THROUGH.. THERE ARE NO PARTS MISSING FROM THE CUTTING BLOCK. ALL PARTS WERE RETRIEVED AND ARE BEING SENT BACK TO THE OFFICE TONIGHT (B)(6) 2021). PLEASE SEND A REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297761 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ONE OF THE SPIKES ON THE BACK OF THE SPECIALIST TWO SIZE 4 FEMORAL CUTTING BLOCK IS BENT DUE TO EXCESSIVE USE. NO PIECES BROKE OFF AND A REPLACEMENT IS NEEDED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11058394 ↗
• MalfunctionNov 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SZ 4 CUT BLOCK WAS PINCHED ON CHAMFER SLOTS. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10875415 ↗
• MalfunctionOct 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIZE 4 4 IN 1 CUT BLOCK WAS BENT DURING SURGERY. NO PIECES WERE BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670745 ↗
• MalfunctionAug 20, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING BLOCK HAS WORN DOWN OVER TIME AND THE SAW NO LONGER ENTERS SMOOTHLY AND AFFECTS THE SURGEONS CUTS. IT WAS NOT USED IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433933 ↗
• MalfunctionJul 22, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC INSERT TRIAL BROKE WHEN THEY TOOK IT OUT TO PUT IN THE FINAL IMPLANTS. ALSO, SECONDARY IMPACTOR BROKE DURING FINAL IMPACTION. LASTLY, THE CUTTING GUIDE BROKE WHEN THEY STRUCK WITH A MALLET TO PUT IN PLACE BEFORE CONVERGING THE PINS. ALL ITEMS WERE RETRIEVED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10309402 ↗
• MalfunctionMay 26, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ANTERIOR CHAMFER SLOT ON THE CUT BLOCK IS DAMAGED AND THE SAWBLADE NO LONGER FITS. NEED TO BE REPLACED. SURGICAL DELAY OF 2 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 10088570 ↗
• MalfunctionOct 10, 2019Difficult to Remove; Material Deformation; Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking; Difficult to Remove; Material Deformation; Material Twisted/Bent; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SIZE 4 FEMORAL CUT BLOCK WAS BENT AND CATCHING THE SAW BLADE DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175429 ↗
• MalfunctionJul 8, 2019Break; Break

  THAT DEVICE WAS REPORTED AS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768400 ↗
• MalfunctionJul 8, 2019Break; Break

  THE DEVICE WAS REPORTED AS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767664 ↗
• MalfunctionApr 8, 2019Material Deformation; Material Deformation

  THE CUTTING GUIDE WAS DEFORMED, SO IT GIVES AN IMPRECISE CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492552 ↗
• MalfunctionApr 8, 2019Material Deformation; Material Deformation

  THE CUTTING GUIDE WAS DEFORMED SO HE GIVES AN IMPRECISE CUT. CUSTOMER REFERENCE/PO/SERVICE --> PO# (B)(4). DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO CONSEQUENCE. 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). 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 Consequences Or Impact To Patient

  MAUDE report 8492537 ↗
• MalfunctionSep 7, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CHAMFER BLOCK ANTERIOR CHANGER SLOT IS BENT IN, IT DOES NOT ALLOW A SAW BLADE TO PASS THROUGH IT. ALL PARTS OF THIS DEVICE HAVE BEEN RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854776 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE 4 IN 1 POPUP BLOCK WAS BROKEN DURING SURGERY. IT ALSO STATES THAT THE TOP SAW CAPTURE WAS BROKEN OFF. NO SURGICAL DELAY. ALL PIECES RETRIEVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122435 ↗