R3 71935349Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556613757), received between May 13, 2021 and Nov 5, 2024 — classified as 3 malfunctions.

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

• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TOP PIECE OF ONE (1) ACETABULAR REAMER HANDLE - OFFSET BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610119 ↗
• MalfunctionDec 7, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A THR SURGERY, THE ACETABULAR REAMER HANDLE - OFFSET BOUND UP DURING ACETABULAR REAMING AND WAS LATER FOUND TO BE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283642 ↗
• MalfunctionMay 13, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING INSPECTION OR SET UP BEFORE A THR SURGERY. WHILE ATTEMPTING TO ASSEMBLE AND DISASSEMBLE, THE TECH WAS UNABLE TO REMOVE THE SHAFT OF THE ACETABULAR REAMER HANDLE - OFFSET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822276 ↗