APEX 5016-5-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327091885), received between Mar 15, 2024 and Mar 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 15, 2024Break; Fracture; Break; Fracture

  THE FOLLOWING EVENT WAS RECEIVED THROUGH BFARM USER REPORT: "WHEN INSERTING THE FIXATOR PIN UNDER TYPICAL CONDITIONS, IT HAPPENED TWICE THAT BOTH PINS FROM THE SAME BATCH BROKE OFF IN EXACTLY THE SAME PLACE. THE REMNANTS HAD TO BE CHISELED OUT OF THE BONE. THE PREDETERMINED BREAKING POINT HAD TO BE BRIDGED. THESE ARE "SELF-TAPPING / SELF-DRILLING" PINS."

  Patient problems: Perforation

  MAUDE report 18911885 ↗
• InjuryMar 15, 2024Break; Fracture; Break; Fracture

  THE FOLLOWING EVENT WAS RECEIVED THROUGH BFARM USER REPORT: "WHEN INSERTING THE FIXATOR PIN UNDER TYPICAL CONDITIONS, IT HAPPENED TWICE THAT BOTH PINS FROM THE SAME BATCH BROKE OFF IN EXACTLY THE SAME PLACE. THE REMNANTS HAD TO BE CHISELED OUT OF THE BONE. THE PREDETERMINED BREAKING POINT HAD TO BE BRIDGED. THESE ARE "SELF-TAPPING / SELF-DRILLING" PINS."

  Patient problems: Perforation

  MAUDE report 18911841 ↗