SIGMA HIGH PERFORMANCE 9505-01-174Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224945), received between May 23, 2023 and Aug 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE PIN HOLE IN THE BLOCK WOULD NOT ACCEPT THE APPROPRIATE PIN FOR FIXATION TO THE BONE SURGERY WAS DELAYED 1 MINUTE DUE TO THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20003213 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN HOLE SEEMS TO BE DEFORMED IN THE BLOCK. THE APPROPRIATE PIN BECAME STUCK IN THE PIN HOLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? PULLED THE PIN AND BLOCK OUT TOGETHER AFTER MAKING THE RESECTION, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?-- NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, (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 18864820 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PRIMARY TOTAL KNEE ARTHROPLASTY, SMOOTH PIN GOT STUCK IN THE MINIMALLY INVASIVE LEFT 0 DEGREE CUTTING BLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986851 ↗