MULTILOC 04.019.285SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982090119), received between Feb 13, 2023 and Feb 13, 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 16, 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.

• MalfunctionFeb 13, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A HUMERAL NAIL OPERATION USING THE MULTILOC FOR MULTI MYELOMA CONDITION. THE PATIENT HAD RECENTLY UNDERGONE THE SAME OPERATION BUT ON THE OTHER HUMERUS. ENTRY POINT WAS FOUND AND OPENED IN THE CORRECT SURGICAL TECHNIQUE. AS THE SURGEON HAD USED Ø8.5 ON THE OTHER SIDE HE OPTED TO USE THE SAME DIAMETER FOR THE LEFT. NAIL INSERTED EASILY THROUGH THE PROXIMAL END OF THE HUMERUS AND MID SHAFT FRACTURE BUT INSERTION INTO THE DISTAL END WAS AIDED BY USE OF HAMMER. THE IM CANAL WAS NOT REAMED BEFORE THE NAIL INSERTION. WHEN THE SURGEON WAS TRYING TO ALIGN AND ROTATE THE NAIL SO DISTAL HOLES WERE ALIGNED CORRECTLY AND THE PROXIMAL END WAS ALSO ALIGNED, HE WAS HAVING TO USE CONSIDERABLE FORCE. AFTER SOME TIME OF TRYING TO ROTATE IT WAS NOTICED THAT THE CONNECTING SCREW WAS ROTATING WHEN ROTATING THE ARM TO CHECK BOTH VIEWS. THE SURGEON REMOVED THE NAIL, WHICH WAS WHEN IT WAS NOTICED THAT THE VERY PROXIMAL END OF THE NAIL WAS DAMAGED AT THE INSERTION ARM / NAIL CONNECTION JOINT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 8.5MM TI MULTILOC HUMERAL NAIL L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363841 ↗