INSTRUMENT 6266-5-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327219692), received between Aug 3, 2020 and Aug 3, 2020 — classified as 1 injury.

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

• InjuryAug 3, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE AWL SNAPPED AT THE MID-SHAFT OF THE FEMORAL CANAL. A HOLE HAD TO BE CUT IN THE PATIENT'S FEMUR DISTALLY TO THE TIP IN ORDER TO REMOVE ALL PIECES OF THE DEVICE. SURGEON IS AN EXPERIENCED USER OF THE SYSTEM AND THERE WAS NOTHING UNUSUAL IN THE WAY THE DEVICE WAS BEING USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 HOUR. REP CAN PROVIDE PICTURES OF THE DEVICE AND CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10355090 ↗