INSTRUMENT 6266-5-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327219685), received between Mar 5, 2021 and Mar 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• MalfunctionMar 11, 2022Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT WHILE MANUALLY INSERTING THE STARTER REAMER INTO THE PATIENT'S FEMUR, THE INSTRUMENT BROKE IN HALF. BOTH PIECES WERE REMOVED AND PUT TOGETHER AT THE BACK TABLE TO ENSURE NOTHING REMAINED IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10-12 MINUTES. REP REPORTED THAT A PICTURE OF THE DEVICE CAN BE PROVIDED AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13729006 ↗
• InjuryMar 5, 2021Fracture; Fracture

  WHEN THE REAMER WAS INTRODUCED INTO THE FEMUR ON HAND POWER IT SNAPPED OFF WITH A PORTION LEFT INTO THE FEMUR. WHICH RESULTED IN THE SURGEON CUTTING A WINDOW DISTALLY TO RETRIEVE THE BROKEN PIECE. THE FEMUR ALSO FRACTURED WHICH REQUIRED A RESTORATION HIP STEM. IT ADDED 2 HOURS TO THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11423116 ↗