MULTILOC 03.019.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982069474), received between Apr 16, 2020 and Apr 14, 2023 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR FRACTURE OF RIGHT HUMERAL SHAFT IN (B)(6) 2022. IN THE SURGERY, THE NAIL IN QUESTION WAS INTENTIONALLY IMPLANTED EXCESSIVELY TO PREVENT IMPINGEMENT, AND A 10 MM END CAP WAS USED. THE PROXIMAL PART OF THE NAIL WAS LOCKED WITH THE 2 SCREWS IN QUESTION, AND THE DISTAL PART WAS LOCKED WITH 3 LOCKING SCREWS. THE POSTOPERATIVE COURSE WAS GOOD, AND THE IMPLANTS USED IN THE INITIAL SURGERY WERE TO BE REMOVED ON (B)(6) 2023. IN THE REMOVAL SURGERY, OPERATIONS WERE PROCEEDED, AND THE ISSUES WERE OCCURRED AS FOLLOWS: AFTER REMOVING THE END CAP, THE SURGEON HAD A DIFFICULTY IN CONNECTING THE EXTRACTION SCREW TO THE NAIL BECAUSE THE DISK-SHAPED OVERHANG AROUND THE CONNECTION PART OF THE EXTRACTION SCREW INTERFERED WITH THE BONE AND SOFT TISSUE AROUND THE EXTRACTION SCREW. THE SURGEON ATTEMPTED TO EXTRACT THE 2 SCREWS IN QUESTION, BUT THE SURGEON HAD A DIFFICULTY IN EXTRACTING THEM DUE TO BONE INGROWTH AND THE DEFORMITY OF THE SCREW HEADS. THE 3 LOCKING SCREWS AT THE DISTAL PART OF THE NAIL WERE EXTRACTED SUCCESSFULLY WITH NO PROBLEM. EVENTUALLY, THE NAIL WAS SUCCEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747030 ↗
• MalfunctionApr 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE EXTRACTION SHAFT. DURING THE REMOVAL OF A SCREW THE SURGEON HAD DIFFICULTY IN REMOVING THE SCREW BECAUSE HE COULD NOT ENGAGE THE EXTRACTION SHAFT TO THE SCREW HEAD. THE SURGEON MANAGED TO REMOVE THE SCREW WITH THE EXTRACTION SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) EXTRACTION SHAFT F/4.5MM TI MULTILOC SCREWS/QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968116 ↗