ATTUNE 2545-00-049Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295396154), received between Jul 11, 2017 and Mar 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT SZ 7 TIBIAL PLATE AND PATELLA/FEMORAL DRILL BIT ARE CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604589 ↗
• MalfunctionFeb 2, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE NURSE IDENTIFIED FEMORAL LUG DRILL AS BEING DAMAGED BEFORE CASE BEGAN. SWAPPED FOR AN INTACT INSTRUMENT OFF ANOTHER TRAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233811 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT THE FULL 32 DOME PATELLA PEG BROKE, AND THE TIBIAL ALIGNMENT HANDLE AND THE INSPECTION HANDLE ALSO BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201142 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PAT/FEM DRILL WAS NOT SHARP ENOUGH AND COULDN'T CLEAR THE LUG HOLES OUT WELL ENOUGH ON THE PATELLA. A 2ND DRILL WAS USED, SO THERE WERE NO PROBLEMS BESIDES A DELAY OF A MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757574 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT THE LUG DRILL METAL CHIPPING.

  Patient problems: Insufficient Information

  MAUDE report 18139419 ↗
• MalfunctionNov 8, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY SINCE THIS WAS NOTICED AT THE BEGINNING OF THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18092690 ↗
• MalfunctionSep 26, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE ARTHROPLASTY, THE SURGEON DISCOVERED SOME DEBRIS THAT HE ASCERTAINED MUST HAVE COME FROM A WORN PATELLOFEMORAL DRILL DURING THE FEMORAL LUG DRILL STEP. THE PATELLOFEMORAL DRILL WAS REMOVED FROM CIRCULATION. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816255 ↗
• MalfunctionJun 21, 2022Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE SURGEON REQUESTED NEW ATTUNE LUG HOLE DRILL BITS AND STATED THAT THEY WERE GETTING DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754130 ↗
• MalfunctionJun 21, 2022Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE SURGEON REQUESTED NEW ATTUNE LUG HOLE DRILL BITS AND STATED THAT THEY WERE GETTING DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754123 ↗
• MalfunctionOct 11, 2018Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE PATELLA CLAMP DOES NOT GRIP TIGHT ENOUGH WHEN USING THE CLAMP AND PATELLA DRILL BIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956245 ↗
• MalfunctionJul 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON NOTICED A BURR ON THE PATELLA FEMORAL DRILL BIT. THEY REQUESTED A REPLACEMENT. THERE WAS NO CASE/PATIENT INVOLVED IN THIS SITUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707041 ↗
• MalfunctionSep 27, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE DRILL BIT HAS BEEN CHIPPED. THIS HAPPENED DURING ROUTINE INSPECTION IN SPD.

  Patient problems: No Information

  MAUDE report 6899026 ↗
• MalfunctionAug 31, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE ATTUNE FEMORAL LUG/PATELLA DRILL BIT WAS NOTICED TO BE CHEWED UP.

  Patient problems: No Information

  MAUDE report 6833981 ↗
• MalfunctionJul 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TIP OF THE DRILL WAS BROKEN AND METAL SHAVINGS WERE COMING OFF IT. THIS HAPPENED ON THE LAST LUG HOLE TO BE DRILLED.

  Patient problems: No Information

  MAUDE report 6702910 ↗