NA 2245-10-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295107743), received between Feb 4, 2021 and Aug 22, 2022 — classified as 2 malfunctions.

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

• MalfunctionAug 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STRAIGHT AWL TIP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264885 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  INITIAL REPORT: VERY SCLEROTIC BONE. REP PRESENT AND FOLLOWED STANDARD SURGICAL TECHNIQUE. INSTRUMENTS DAMAGED UPON USE. SURGICAL DELAY 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. NO CONSEQUENCE TO PATIENT. FURTHER INFORMATION PROVIDED; THE AWL WAS BENT. THE TIP OF THE PROXIMAL REAMING HANDLE SNAPPED OFF. THE PROXIMAL REAMING GUIDE WAS DAMAGED UPON REMOVAL AS WAS STUCK IN THE PATIENT AFTER THE PROXIMAL REAMING HANDLE SNAPPED. HAD TO REMOVE WITH MOLE WRENCH / PLIERS AND ROUGHED UP THE ENDS.

  Patient problems: Insufficient Information

  MAUDE report 11279284 ↗