NA 1896-5030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540202468), received between May 22, 2019 and Oct 30, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 18, 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 30, 2023Use of Device Problem; Use of Device Problem

  AS REPORTED: "35 MM WAS PLANED TO INSERT, BUT 30MM SCREW WAS INCORRECTLY OPENED AND INSERTED. IT WAS CONFIRMED THAT THE TIP OF THE SCREW PENETRATED THE CORTEX."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034812 ↗
• InjuryMay 22, 2019Material Protrusion/Extrusion

  REP REPORTED THAT THE SURGEON REVISED A GAMMA NAIL TO A REST MOD THA WITH MDM. THE PATIENT RECEIVED THE GAMMA NAIL ABOUT 2 YEARS AGO FOR A FEMORAL FRACTURE, THEN DEVELOPED AVASCULAR NECROSIS. SUBSEQUENT COLLAPSE OF THE FEMORAL HEAD HAS RESULTED IN THE LAG SCREW PROTRUDING INTO THE JOINT SPACE REQUIRING REVISION.

  Patient problems: Necrosis

  MAUDE report 8631345 ↗