NA 2178-63-183Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295096405), received between Dec 3, 2018 and Dec 22, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ALL REAMERS WERE LOOSE ON THE ADAPTERS AND SPUN FREELY. ADAPTER WOULD SPIN FREELY WHEN ATTACHED TO REAMERS OR ANY OTHER ATTACHMENT. T-HANDLE WAS ALSO LOOSE. ATTACHMENT POINT SEEMS TO BE WEAK AND CAME FREE AT FIRST SIGN OF RESISTANCE. NO PIECES WAS BROKEN OFF IN PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 AS A RESULT OF DEPUY INSTRUMENTS NOT FUNCTIONING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 11057657 ↗
• MalfunctionDec 21, 2020Failure to Cut; Material Twisted/Bent; Naturally Worn; Failure to Cut; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046294 ↗
• MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMERS WERE STRIPPED AND DID NOT HOLD ONTO THE CHUCK. NO SURGICAL DELAY HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330801 ↗
• MalfunctionDec 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE ROUNDED OUT AND WOULD NOT STAY LOCKED IN THE HUDSON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124433 ↗