SIGMA 2024-85-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295084037), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SHIM HAS A SLIGHT BENT THAT WILL NOT ALLOW TO SLIDE PROPERLY TO THE CUTTING JIG. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? CHECKING OF STERILE SET PRIOR TO PROCEDURE WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? ACCOUNT HAVE X2 SET TRAY AND THEY OPENED ANOTHER TRAY TO SUFFICE THE BROKEN ITEM. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? N/A. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT. WHILE SCRUB NURSE WAS CHECKING THE STERILE INSTRUMENTS PRIOR TO THE CASE. SHE NOTICE THAT THE ABOVE ITEM HAS A SLIGHT BENT THAT WILL NOT ALLOW TO SLIDE PROPERLY TO THE CUTTING JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103796 ↗