Straight Broach HandleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390098311), received between May 30, 2024 and May 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionMay 30, 2024Mechanical Problem; Mechanical Problem

  DURING A HIP SURGERY PERFORMED ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS NO HANDLE IN THE INSTRUMENT SET FOR THE DIRECT ANTERIOR APPROACH (DAA). THE SURGEON DECIDED TO USE THE STRAIGHT BROACH HANDLE (PRODUCT CODE 9095.11.005, LOT #21AE019) FOR RASPING. DURING THE RASPING, THE HANDLE WAS REMOVED TO SEE IF THE RASP SIZE WAS APPROPRIATE, AND IMAGES WERE CHECKED. WHEN HE TRIED TO ENGAGE THE HANDLE INTO THE RASP TO REMOVE IT, DIFFICULTIES WERE EXPERIENCED, AND THE CALCAR AREA WAS OVERLOADED RESULTING IN BONE FRACTURE. INSTEAD OF THE PLANNED MASTER SL FEMORAL STEM, THE H-MAX C IMPLANT WAS USED TO COMPLETE THE SURGERY. THE CEMENTED STEM WAS FIXED WITHOUT PROBLEM ON THE FRACTURE AREA, AND A BIPOLAR HEAD WAS THEN IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT PROBLEM ON FIXATION, BUT DUE TO THE EVENT THE SURGICAL TIME WAS EXTENDED FOR ABOUT 20 MINUTES. EVENT HAPPENED IN JAPAN.

  Patient problems: Bone Fracture(s)

  MAUDE report 19422446 ↗