NA 2440-00-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295424307), received between Sep 22, 2017 and Mar 17, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Crack; Crack

  COMPLAINT DESCRIPTION: BLACK PORTION ON ACETABULAR REAMER BROKE AT END CLOSEST TO THE ADAPTER JUNCTION INVESTIGATION METHOD: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE DESIGNED SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND DETERMINED THE DEVICE WAS MANUFACTURED OUT OF THE CORRECT MATERIALS AND TO ALL PRINT SPECIFICATIONS. REOPENED - PRODUCT RECEIVED. INVESTIGATION SUMMARY: TERRITORY 230 REPORTS THE BLACK PORTION ON ACETABULAR REAMER BROKE AT END CLOSEST TO THE ADAPTER JUNCTION. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE DESIGNED SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND DETERMINED THE DEVICE WAS MANUFACTURED OUT OF THE CORRECT MATERIALS AND TO ALL PRINT SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. REOPENED - PRODUCT RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845896 ↗
• MalfunctionDec 14, 2018Break; Break

  REAMER HANDLE HAS A PIECE BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163954 ↗
• MalfunctionNov 21, 2018Crack; Crack

  IT WAS REPORTED THAT THE PLASTIC SLEEVE CRACKED ON THE REAMER HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095477 ↗
• MalfunctionNov 21, 2018Crack; Crack

  IT WAS REPORTED THAT THE PLASTIC SLEEVE CRACKED ON THE REAMER HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095459 ↗
• MalfunctionNov 21, 2018Crack; Crack

  IT WAS REPORTED THAT THE REAMER HANDLE IS STARTING TO CRACK FROM EXCESSIVE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094259 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISMS OF THE INSTRUMENTS DID NOT STAY LOCKED INTO PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085156 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISMS OF THE INSTRUMENTS DID NOT STAY LOCKED INTO PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085131 ↗
• MalfunctionNov 5, 2018Break; Break

  IT WAS REPORTED THAT THE BASE OF THE REAMER HANDLE WAS CHIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037717 ↗
• MalfunctionSep 25, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ACE REAMER HANDLE WON'T HOLD ACETABULUM REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907798 ↗
• MalfunctionSep 22, 2017Bent; Connection Problem; Bent; Connection Problem

  IT WAS REPORTED THAT THE WHILE PUTTING THE INSTRUMENTS TOGETHER THE QUICKSET GRATER HANDLE WAS NOTICED DAMAGED. THE CONNECTION TO THE GRATER HEAD WAS BENT AND IT WON'T HOLD THE GRATER HEAD SUFFICIENTLY.

  Patient problems: No Information

  MAUDE report 6886861 ↗