SIGMA 9505-01-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295225416), received between Jul 25, 2017 and Nov 30, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING BLOCK- WHEN DRILLING FOR FIXATION PINS, THE BLOCK WOULD CATCH THE DRILL BIT AND NOT ALLOW IT TO ADVANCE. FEMORAL IMPACTOR- DURING IMPLANT IMPACTION A SMALL PIECE FROM THE FEMORAL IMPACTOR BROKE OFF AND THE IMPACTOR ALSO HAS A CRACK IN IT. ARTICULAR SURFACE- DURING REMOVAL OF TRIALS THE ARTICULAR SURFACE WAS REMOVED AND THE POST WITH THE SPRING SNAPPED OFF. THERE WAS A 10MIN OF SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886124 ↗
• MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT'S LEFT KNEE JOINT. DURING THE SURGERY, WHEN THE SURGEON CUT THE DISTAL FEMUR, HE HAD A DIFFICULTY CUTTING BECAUSE THE GAP OF SLIT TO INSERT A BLADE WAS TOO EXTENSIVE. THE SURGEON USED A BLADE (1.27 MM THICK AND 19 MM WIDE). THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITHIN 30 MINUTES DELAY. DURATION OF REPLACING THE DEVISE WAS WASTING TIME. THE SURGEON COMMENTED THAT THE THICKNESS OF THE SLIT OF THE BLADE ENTRY SIDE AND OUT SIDE IS DIFFERENT, AND THE SLIT NEAR THE CENTER APPEARS TO BE WORN AND EXTENDED BY VISUAL LEVEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10801901 ↗
• MalfunctionSep 14, 2020Break; Material Twisted/Bent; Mechanical Jam; Break; Material Twisted/Bent; Mechanical Jam

  DURING SURGERY, THE SURGEON WAS REMOVING PINS FROM JIG, HE BENT AND SNAPPED THE PIN IN THE JIG AND IT WAS UNABLE TO BE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530022 ↗
• MalfunctionJun 19, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DIAGONAL PIN COLD WELDED INTO BLOCK, UNABLE TO REPAIR. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713137 ↗
• MalfunctionApr 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UNABLE TO FIT PIN THROUGH ONE OF PIN HOLES. OCCURRED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489078 ↗
• MalfunctionAug 29, 2018Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE PIN GOT STUCK IN THE BLOCK. THE HOLE IS NO LONGER SMOOTH AND THE BLOCK NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7826659 ↗
• MalfunctionJul 25, 2017Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE OFF INSIDE THE SIGMA DISTAL FEMORAL CUTTING BLOCK.

  Patient problems: No Information

  MAUDE report 6739899 ↗