NA 2178-56-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295095460), received between Nov 25, 2019 and Oct 22, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IM DRILL DID NOT CONNECT TO HUDSON ADAPTOR.

  Patient problems: Insufficient Information

  MAUDE report 20504935 ↗
• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IM DRILL DID NOT CONNECT TO HUDSON ADAPTOR.

  Patient problems: Insufficient Information

  MAUDE report 20504922 ↗
• MalfunctionMay 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IM DRILL WOULD NO LONGER ATTACH TO HUDSON ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313163 ↗
• MalfunctionMay 3, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIP OF THE IM DRILL IS NO LONGER SHARP. IT NEEDS TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19237265 ↗
• MalfunctionMay 3, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIP OF THE IM DRILL IS NO LONGER SHARP. IT NEEDS TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19237232 ↗
• MalfunctionMay 3, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TIP OF THE IM DRILL IS NO LONGER SHARP. IT NEEDS TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19237192 ↗
• InjuryJan 19, 2022Off-Label Use; Off-Label Use

  WRONG INSTRUMENT WAS PROVIDED IN THE INSTRUMENT SET. PROBABLY DUE TO A MISDIRECTION OF THE DRILL BIT DURING ITS PASSAGE AND ACCENTUATED BY THE POINTED END OF THIS INSTRUMENT, THE SURGEON CROSSED THE ANTERIOR CORTEX OF THE FEMUR. UNFORTUNATELY, DURING THE NIGHT, THE PATIENT FELL OUT OF BED AND FRACTURED HER FEMUR AT THIS FRAGILE POINT. THIS RESULTED IN A SECOND SURGICAL INTERVENTION.

  Patient problems: Fall; Limb Fracture

  MAUDE report 13293085 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297892 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297836 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297787 ↗
• MalfunctionNov 25, 2019Corroded; Crack; Corroded; Crack

  IT WAS REPORTED THAT THE IM REAMER HAD SOME PITTING SPOTS ON IT AND THE 2.5 10MM TC3 RP INSERT TRIAL HAD A CRACK IN IT. THESE WERE FOUND OUT DURING INSPECTION AFTER DECONTAMINATION. BOTH NEEDS REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371230 ↗