SPECIALIST 96-6143Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295246985), received between Aug 15, 2017 and Sep 29, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THAT TO THIS PIECE, A SCREW IS BROKEN THAT HOLDS THE TONGUE OF THE PREVIOUS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508061 ↗
• MalfunctionDec 29, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT IS WORN FROM MULTIPLE PASSES WITH SAW BLADE OVER THE YEARS AND HAS LEFT BURRS MAKING IT DIFFICULT TO PASS A SAW BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13109197 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED AS "BENT SPIKE ON THE BACK OF THE CUTTING BLOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012946 ↗
• MalfunctionNov 19, 2021Naturally Worn; Naturally Worn

  IT SHOULD BE NOTED THAT ALL PRODUCT HAS NOT FAILED, IT HAS WORN OUT DUE TO MULTIPLE USE OR A NUMBER OF YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843728 ↗
• MalfunctionMar 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SAW BLADE WOULD NOT GO THROUGH THE CUTTING BLOCK, BUT WOULD GO THROUGH EVERY OTHER BLOCK. THERE WAS NO OBVIOUS BLOCKAGE. THEY OPENED ANOTHER SET AND THAT BLOCK WORKED FINE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9873987 ↗
• MalfunctionJul 26, 2019Break; Break

  IT WAS REPORTED THAT THE DEPUY CUTTING BLOCK WAS BROKEN DURING SURGERY. S23/REF (B)(4). NO IMPLANT WERE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833603 ↗
• 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 8492656 ↗
• 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 8492653 ↗
• MalfunctionFeb 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  SIGMA SZ3 CUT BLOCK MOVING PARTS WON'T HOLD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349545 ↗
• MalfunctionAug 15, 2017Bent; Bent

  IT WAS REPORTED THAT ONE OF THE SPIKES ON THE SIZE 3 SP2 4 IN 1 CUTTING BLOCKS IS BENT.

  Patient problems: No Information

  MAUDE report 6796505 ↗