OMEGA 704005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327079111), received between Aug 22, 2019 and May 17, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2021Mechanics Altered; Mechanics Altered

  THE CUSTOMER REPORTED THAT THE TRIPLE BARRELED REAMER WHICH SHOULD FIX IN SITU BECAME LOSE WHILE REAMING AND THE WIRE IT WAS REAMING OVER BECAME STUCK AND HAD TO BE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836388 ↗
• MalfunctionMay 27, 2020Mechanics Altered; Mechanics Altered

  THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM THAT CONTROLS THE DEPTH OF THE DHS REAMER IS FAILING. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10092904 ↗
• MalfunctionMay 27, 2020Mechanics Altered; Mechanics Altered

  THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM THAT CONTROLS THE DEPTH OF THE DHS REAMER IS FAILING. NO ADVERSE EVENTS WERE RECORDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10092899 ↗
• MalfunctionMay 27, 2020Mechanics Altered; Mechanics Altered

  THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM THAT CONTROLS THE DEPTH OF THE DHS REAMER IS FAILING. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10092891 ↗
• MalfunctionMay 27, 2020Mechanics Altered; Mechanics Altered

  THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM THAT CONTROLS THE DEPTH OF THE DHS REAMER IS FAILING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10092889 ↗
• MalfunctionAug 23, 2019Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THEY SET THE DEVICE TO A SPECIFIC LENGTH AND WHEN THEY WE USING IT IN THE CASE IS CONTINUED TO ADVANCE. THEY STOPPED DRILLING. THERE WAS A DELAY OF 5 MINUTES WHILE THEY CHECKED IF THE DEVICE WAS PROPERLY LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927317 ↗
• MalfunctionAug 23, 2019Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT THEY SET THE DEVICE TO A SPECIFIC LENGTH AND WHEN THEY WE USING IT IN THE CASE IS CONTINUED TO ADVANCE. THEY STOPPED DRILLING. THERE WAS A DELAY OF 5 MINUTES WHILE THEY CHECKED IF THE DEVICE WAS PROPERLY LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927314 ↗
• MalfunctionAug 22, 2019Defective Device

  THE CUSTOMER REPORTED THAT THEY SET THE DEVICE TO A SPECIFIC LENGTH AND WHEN THEY WERE USING IT IN THE CASE IT CONTINUED TO ADVANCE. THEY STOPPED DRILLING. THERE WAS A DELAY OF 5 MINUTES WHILE THEY CHECKED IF THE DEVICE WAS PROPERLY LOCKED. NO ADVERSE EVENTS. THIS DEVICE WAS USED TO COMPLETE THE CASE. THE CUSTOMER COULD NOT REMEMBER WHICH SET WAS BEING USED AT THE TIME (2 POSSIBLE ITEMS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923006 ↗
• MalfunctionAug 22, 2019Use of Device Problem

  THE CUSTOMER REPORTED THAT THEY SET THE DEVICE TO A SPECIFIC LENGTH AND WHEN THEY WERE USING IT IN THE CASE IT CONTINUED TO ADVANCE. THEY STOPPED DRILLING. THERE WAS A DELAY OF 5 MINUTES WHILE THEY CHECKED IF THE DEVICE WAS PROPERLY LOCKED. NO ADVERSE EVENTS. THIS DEVICE WAS USED TO COMPLETE THE CASE. THE CUSTOMER COULD NOT REMEMBER WHICH SET WAS BEING USED AT THE TIME (2 POSSIBLE ITEMS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8922846 ↗