T2 1896-5040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153179399), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 injury.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2018Break

  GAMMA3 NAIL WOULD BE REMOVED AND REPLACED FOR A TOTAL HIP PROSTHESIS ON (B)(6) 2018 BY DR. (B)(6) TOTAL HIP PROSTHESIS UNKNOWN. GAMMA3 NAIL PLACED ON (B)(6) 2013 BY DR. (B)(6). NOT KNOWN HOW THAT OPERATION WENT. ONE DISTAL SCREW IS PLACED IN THE STATIC HOLE. ON X-RAY PHOTO IT HAS BEEN FOUND THAT THE DISTAL SCREW IS BROKEN. PROXIMAL PART SEEMS TO BE INTACT AT THAT MOMENT. THE COLLUM SCREW IS REMOVED AND THEN THE EXTRACTOR IS ATTACHED TO THE NAIL. DISTAL SCREW THE LATERAL PART IS REMOVED. WHEN REMOVING THE GAMMA3 PEN WITH EXTRACTOR, THE UPPER PART BREAKS OFF. REMAINDER OF THE PEN IS REMOVED WITH HOOK WIRE. THE MEDIAL PART OF THE DISTAL SCREW REMAINS IN THE PATIENT AND APPEARS TO CAUSE DAMAGE TO THE CORTEX. IT IS DECIDED TO FIRST MAKE A CT AND THEN DECIDE WHICH PROSTHESIS CAN BEST BE PLACED. NEW TOTAL HIP SURGERY WAS POSTPONED, PATIENT STILL HAS A PART OF THE DISTAL SCREW IN BODY. A CT SCAN HAS TO BE PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7923974 ↗