MULTILOC 04.016.240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089267), received between Dec 30, 2020 and Sep 20, 2021 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE, WHILE INSERTING AN INTERLOCKING MULTLILOC SCREW, THE SCREW WAS TOO SHORT. THE SURGEON CONTINUED TO TRY TO INSERT THE MULTILOC SCREW POSSIBLE STRIPPING OUT THE PLASTIC INSERT OF THE MULTILOC HUMERAL NAIL. THE SCREW WAS PULLED OUT OF THE BONE AND NAIL, AND ABANDONED THAT SCREW HOLE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE(5) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - INSERTION INSTRUMENTS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495719 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AND WAS CONVERTED TO SMITH AND NEPHEW PROXIMAL HUMERUS PLATE SURGERY DUE TO NONUNION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LULTILOC HUMRAL NAILING SYSTEM ON AN UNKNOWN DATE. THE MULTILOC WAS REMOVED WITHOUT ISSUE. CONCOMITANT DEVICES REPORTED: SCREWS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11095467 ↗