ATTUNE 2545-00-467Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295433101), received between May 14, 2020 and Dec 18, 2025 — classified as 4 malfunctions.

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

• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DRILL GUIDE HAD A BURR PREVENTING CENTER SLEEVE FROM FITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846181 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE IMPACTOR WAS WRONGLY INSERTED AND IMPACTED WHICH BROKE THE HANDLE, KEEL AND TOWER WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-01826067, DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01826068, DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF:NONE, IP-01826069, DEVICE PROPERTY OF:NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686671 ↗
• MalfunctionMay 19, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE TOP OF THE SZ 7 ATTUNE NON-CEMENTED DRILL PEG TOWER WAS DAMAGED AND WOULD NOT ALLOW THE CENTRAL REAMER TO PASS THROUGH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072819 ↗
• MalfunctionMay 14, 2020Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE TOP WALL OF THE ATTUNE SIZE 7 NON-CEMENTED DRILL PEG TOWER WAS DAMAGED AND WILL NOT ALLOW TIBIAL DRILL TO PASS THROUGH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10057286 ↗