APEX 5018-5-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327091908), received between Jan 28, 2022 and Feb 17, 2022 — classified as 2 malfunctions.

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. 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.

• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING IN THE MOTOR A 5 MM FICHE DIAMETER OF THE HOFFMAN 3 IN ITS OWN GUIDE (THEY VERIFIED THAT THE GUIDE WAS THE CORRECT ONE FOR THE 5 MM DIAMETER), AFTER ABOUT 10 SECONDS THE SURGEON REPORTED AN OVERHEATING AND A BLOCKAGE OF THE FICHE IN THE GUIDE, AS IF A ¿MERGER¿ HAS HAPPENED." 1/21/2022 - ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "THE PIN THAT GOT STUCK IN THE GUIDE (ONLY ONE HAPPENED, THEN I CHANGED THE TECHNIQUE) OBVIOUSLY HAS THE CODE COVERED, FOR THE OTHER PIN AS YOU CAN SEE FROM THE OTHER IMAGE IT HAPPENED THAT THE TIP BROKE, WHICH HAS NEVER HAPPENED TO ME BY HEART. I CONFIRM THAT I HAVE USED THE DRILL, I KNOW THAT THE TECHNIQUE DOES NOT PROVIDE THIS, BUT I HAVE BEEN IMPLANTING FIXATORS FOR 10 YEARS AND IT HAD NEVER HAPPENED TO ME THAT A PIN BROKE, IN THE CASE OF THE PIN THAT GOT STUCK IN THE GUIDE IT HAD ALREADY HAPPENED TO A COLLEAGUE OF MINE BUT THEN WE FORGOT TO REPORT IT TO YOU. THE PATIENT IS FINE, HE HAS ALREADY BEEN OPERATED FOR THE CONVERSION TO DEFINITIVE SYNTHESIS WITH SUCCESS, WE ONLY HAD A MODEST DILATION OF THE OPERATING TIMES. THE PROCEDURE, ALBEIT WITH DELAY, WAS SUCCESSFULLY COMPLETED. TO OVERCO

  Patient problems: Foreign Body In Patient

  MAUDE report 13552448 ↗
• MalfunctionJan 28, 2022Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING IN THE MOTOR A 5 MM FICHE DIAMETER OF THE HOFFMAN 3 IN ITS OWN GUIDE (THEY VERIFIED THAT THE GUIDE WAS THE CORRECT ONE FOR THE 5 MM DIAMETER), AFTER ABOUT 10 SECONDS THE SURGEON REPORTED AN OVERHEATING AND A BLOCKAGE OF THE FICHE IN THE GUIDE, AS IF A ¿MERGER¿ HAS HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388742 ↗