SIGMA 9505-02-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295228530), received between Dec 16, 2019 and May 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL PREP SET HAS SLIGHTLY DAMAGED CUTTING BLOCKS. SAW BLADE WONT GO THROUGH AS BEEN CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861715 ↗
• MalfunctionFeb 7, 2023Scratched Material; Scratched Material

  IT WAS REPORTED ON THE BOX FOR TRAY 2, SEVERAL PLASTIC PARTS CAME OF THE BOX WHEN IT WAS WASHED AND THE NOTCH IMPACTOR IS WAY TO SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314350 ↗
• MalfunctionJan 5, 2021Scratched Material; Scratched Material

  CUTTING BLOCKS HAVE BEEN INSPECTED AND HOSPITAL NOT HAPPY TO LEAVE THE BLOCKS IN THEIR TRAYS IN THEIR CURRENT STATE. TOO MANY SCUFF MARKS AND SAW BLADE SCIVE MARKS WITH SOME SLIGHTLY SHARP METAL KNICKS IN MULTIPLE AREAS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, 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)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6). 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 11119582 ↗
• MalfunctionDec 16, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE THREADED PIN GOT STUCK IN THE CUTTING BLOCK. ONE THEY COULD TAKE OUT BUT QUITE DEFORMED THE OTHER ONE WAS STUCK COMPLETELY.

  Patient problems: Not Applicable

  MAUDE report 9476972 ↗