MULTILOC 03.019.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982069719), received between May 27, 2021 and May 27, 2021 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895014 ↗