MULTILOC 04.016.270SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089281), received between Jan 31, 2018 and Oct 25, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT AFTER INSERTING THE PIN, THEY WERE UNABLE TO PASS THE DRILL AND THEREFORE COULD NOT INSERT THE SCREWS. AFTER ATTEMPTS REMOVED THAT PIN AND PUT ANOTHER AND WITH THE SAME INSTRUMENTAL IT WAS POSSIBLE TO DO THE ENTIRE PROCEDURE. REGARDING THE SCREW THERE WAS NOTHING, BECAUSE THEN A NEW NAIL WAS INTRODUCED, AND EVERYTHING WENT WELL. THERE ARE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238163 ↗
• InjuryJan 31, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO A BROKEN MULTILOC NAIL AND NONUNION OF LEFT DISTAL HUMERUS. THE NAIL WAS REMOVED, THE NONUNION WAS REDUCED, AND AN EXTRA ARTICULAR DISTAL HUMERUS PLATE WAS APPLIED. THE SURGEON OPTED TO UTILIZE 5 CC OF VIVIGEN BONE GRAFT TO THE NONUNION SITE. THE SURGEON BELIEVES THE CONSTRUCT WAS ORIGINALLY IMPLANTED A COUPLE OF MONTHS AGO (BY ANOTHER SURGEON/FACILITY). THE SURGEON STATED THAT THE NAIL BROKE DUE TO NONUNION; THE NAIL BROKE AT THE NONUNION SITE AT THE MOST PROXIMAL OF THE DISTAL LOCKING HOLES. PATIENT HAD A PREVIOUS NONUNION AND WAS REVISED WITH THIS NAIL. NO INFORMATION ABOUT FIRST PROCEDURE OR IMPLANTS IS AVAILABLE. SCREWS AND END CAP CAME OUT EASILY BUT NAIL TOOK SOME TIME. PROCEDURE COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES 1 (ONE) DEVICE. CONCOMITANT DEVICES: END-CAP (PART#: 04.019.015, LOT #: UNK, QTY: 1). MULTILOC SCREW (PART #: 04.019.044, LOT #: UNK, QTY: 1). LOCKING SCREW (PART #: 04.005.418, LOT #: UNK, QTY: 1). THIS COMPLAINT IS FOR ONE (1) NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7231087 ↗