APEX 5018-5-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327091960), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2017Fracture; Fracture

  IT WAS REPORTED VIA FDA REPORT NUMBER (B)(4) THAT WHILE REAMING THE LEFT FEMORAL SHAFT, THE TIP OF A SHANTZ PIN BROKE OFF IN THE WOUND. THE PIECE WAS NOT VISIBLE AND WAS UNABLE TO BE REMOVED. THE SURGEON IS AWARE AND DID NOT REQUEST ANY FURTHER INTERVENTION. SHANTZ PINS ARE IMPLANTABLE BUT THIS PIN WAS BEING USED FOR INTRAOP FIXATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6788705 ↗