NA 1806-0400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196507), received between Sep 4, 2015 and Sep 5, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: THE INCIDENT OCCURRED IN THE OPERATING ROOM ON (B)(6) 2022 AND CONCERNED THE PLACEMENT OF A T2 TIBIAL NAIL. AFTER THE NAIL WAS PLACED, IT WAS IMPOSSIBLE TO REMOVE THE NAIL ANCILLARY. THE FIXATION SCREW ASSEMBLY, TIBIA NAIL HANDLE AND NAIL SEIZED. THE NAIL HAD TO BE REMOVED FROM THE PATIENT (WITH THE HANDLE STILL PRESENT AT THE END) AND ANOTHER ONE HAD TO BE INSERTED (SMALLER SIZE, AS THERE IS ONLY ONE OF EACH SIZE) USING THE SECOND BOX OF ANCILLARY EQUIPMENT PRESENT IN THE OPERATING ROOM. THE OPERATION ENDED WELL FOR THE PATIENT, BUT THE PROCEDURE WAS LENGTHENED AND THE NAIL PLACED WAS SLIGHTLY SHORTER THAN INITIALLY PLANNED. THE NAIL - NAIL HANDLE DISASSEMBLY WAS PERFORMED AFTER THE PROCEDURE: THE NAIL TIP BROKE OFF AND SO DID THE FOLLOWING ANCILLARIES DUE TO THE FACT THAT THEY HAD TO BE FORCED OUT DUE TO SEIZURE. THE EXPLANTED NAIL, THE GIMBAL WRENCH, THE HANDLE AND THE FIXATION SCREW WERE RECOVERED AND DECONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354657 ↗
• MalfunctionSep 4, 2015Break

  IT WAS REPORTED THAT THE SOCKET WRENCH (#(B)(4) SOCKET WRENCH, UNIVERSAL JOINT T2 FEMUR 10MM) WAS BROKEN DURING FIXATION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5055707 ↗