GAMMA 1320-0150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540377753), received between Aug 16, 2019 and Aug 16, 2019 — classified as 1 malfunction.

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

• MalfunctionAug 16, 2019Entrapment of Device; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT FEMUR, WHEN DRILLING THE K-WIRE TROCAR THROUGH THE TROCAR SLEEVE, THE K-WIRE BECAME STUCK IN THE SLEEVE AND COULD NOT BE REMOVED INTRA-OPERATIVELY. THE CONSTRUCT WAS REMOVED AND ANOTHER SLEEVE WAS USED WITH ANOTHER K-WIRE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 5-10 MINUTES. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8900784 ↗