ATTUNE 2545-00-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295427568), received between Feb 7, 2018 and Jan 14, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT BROKEN TIBIAL DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067002 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TKA SURGERY PERFORMED WITH THE DEVICE IN QUESTION. DURING THE PREVIOUS DAY'S EXPLANATION OF THE DEVICE, THE FIT BETWEEN THE TIBIAL DRILL AND THE RED RING WAS NORMAL. DURING THE INSTRUMENT ASSEMBLY BEFORE THE SURGERY, THE TIBIAL DRILL BIT WAS BROKEN, AND THE RED RING DID NOT FIT AND CAME OFF. THE BREAKAGE ITSELF WAS THOUGHT TO HAVE OCCURRED DURING CLEANING. IT DID NOT ENTER THE BODY. DURING THE SURGERY, THE SURGEON MANAGED TO OPERATE IT WELL AND COMPLETED THE DRILLING. IF IT WERE TO BREAK DURING THE OPERATION, IT WOULD BE DANGEROUS BECAUSE IT IS A SMALL PART. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335302 ↗
• MalfunctionJul 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE ATTUNE PATELLA DRILL WAS NOT FUNCTIONING PROPERLY AND DULL. NO PIECES WERE BROKEN OFF. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315022 ↗
• MalfunctionJul 10, 2023Scratched Material; Scratched Material

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JUNE 22, 2023, AN ATTUNE TIBIA DRILL WAS USED DURING A PROCEDURE AND THERE WAS DIFFICULTY WITH THE REAMER PENETRATING DEEP. AFTER CLOSE INSPECTION, BOTH WERE DISCOVERED TO HAVE MULTIPLE DEEP SCRATCHES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR AN ATTUNE TIBIA DRILL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287979 ↗
• MalfunctionMay 10, 2023Break; Material Deformation; Break; Material Deformation

  IT REPORTED THAT IT WAS NOTICED THAT THESE INSTRUMENT WERE DAMAGED OR BEAT UP. INSTRUMENTS ARE CHIPPED OR BENT. NOTHING LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902406 ↗
• MalfunctionFeb 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY. IN THE SURGERY, THE ENGAGEMENT BETWEEN THE ATTUNE TIBIAL DRILL TOWER IN QUESTION AND THE ATTUNE TIBIAL DRILL IN QUESTION WAS NOT GOOD. SO, REAMING OVER THE TOWER WAS NOT POSSIBLE, SO THE SURGEON REAMED MANUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386798 ↗
• MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER KEEPS BINDING IN PREP TOWER. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158038 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  I WAS INFORMED TODAY BY THE ORTHOPEDIC LEAD NURSE OF (B)(6) HOSPITAL ORTHOPEDICS THEATRES THAT THERE IS DAMAGED TO ATTUNE TIBIAL DRILL AND ATTUNE TIBIAL TOWER. THEY WERE BROKEN YESTERDAY (B)(6) 2022. ITEMS DIFFICULT TO ASSEMBLE. TIBIAL DRILL DOES NOT SLIDE INTO THE DRILL TOWER SMOOTHLY. ITEMS NOT REPORTED AS BROKEN, THAT TIBIAL DRILL DOES NOT SLIDE INTO DRILL TOWER AND ID FORCED WILL CREATE METAL CHIPPING. NO HARM TO PATIENT OR STAFF OCCURRED. NO DISRUPTION TO OPERATING TIME OCCURRED, ONLY THAT THEY OPENED THE 2ND ATTUNE TIBIAL PREP TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094950 ↗
• MalfunctionJul 8, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  TIBIAL DRILL GOT BOUND UP DURING THE OPERATION INTO THE TIBIAL TOWER . IT APPEARS IT WAS FROM WEAR AND TEAR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955440 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL STOPS DON¿T STAY ON, BUTTON SEEMS SMASHED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559193 ↗
• MalfunctionDec 20, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LARGE LUG DRILL WAS NOT ABLE TO PASS THROUGH THE DRILL TOWER. THERE WAS A SURGICAL DELAY OF 5 MINUTES TO OPEN ANOTHER TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043802 ↗
• MalfunctionNov 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE REAMING THE TIBIA, THE DRILL BECAME STUCK IN THE TOWER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882197 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRILL WAS RECEIVED WITH A BURR/ROUGH EDGE.

  Patient problems: Insufficient Information

  MAUDE report 12487287 ↗
• MalfunctionAug 25, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA WITH THE REAMER IN QUESTION. DURING THE REAMER USE, IT WAS FOUND THAT THE COLORED LINES OF THE REAMER TO CONFIRM THE REAMER DEPTH MIGHT BE COLORED IN THE OPPOSITE DIRECTION FROM USUAL. THE NORMAL SIZE OF 3-5 LINES WAS RECOGNIZED AS GREEN AND 6-8 LINES AS YELLOW, WHICH WAS ALSO DESCRIBED IN THE SURGICAL TECHNIQUE. HOWEVER, THE LINE OF THE INSTRUMENT USED THIS TIME WAS REVERSED, AND THE 3-5 LINES WERE YELLOW AND THE 6-8 LINES WERE GREEN. ACCORDING TO THE SURGEON, THE DEPTH TO WHICH THE BONE SHOULD BE EXCAVATED IS CHECKED BY THE COLOR OF THE LINE. IF THE COLOR IS OPPOSITE TO THAT OF THE NORMAL ONE, THE BONE MAY BE CUT OFF MORE THAN NECESSARY, WHICH MAY CAUSE AN ACCIDENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365951 ↗
• MalfunctionJul 30, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE TIBIAL DRILL IS NO LONGER SMOOTH AND THE DRILL CATCHES ON THE INSIDE OF THE TOWER AND WILL NOT GO ALL THE WAY DOWN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253383 ↗
• MalfunctionJul 2, 2021Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, ONE INSTRUMENT BROKE DURING THE CASE. WE HAD BACK UP INSTRUMENTS AVAILABLE AND THERE WERE NO DELAYS OR PROBLEMS IN THE CASE BECAUSE OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106843 ↗
• MalfunctionJul 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL STOP WILL NOT STAY ON. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339569 ↗
• MalfunctionMay 20, 2020Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TIBIAL DRILL WAS GETTING STUCKED IN THE TIBIAL TOWER.

  Patient problems: No Code Available

  MAUDE report 10075426 ↗
• MalfunctionFeb 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE ATTUNE TIBIAL DRILL WOULD NOT PASS SMOOTHLY THROUGH THE TIBIAL TOWER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746830 ↗
• MalfunctionJul 17, 2019Naturally Worn; Naturally Worn

  THE DRILL IS CAUSING METAL WEAR IN THE DRILL TOWER. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799376 ↗
• MalfunctionMay 20, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  TIBAL DRILL GETTING STUCK IN TIBIAL TOWER. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? : NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? : YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624723 ↗
• MalfunctionApr 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TIBIAL KEEL DRILL WAS BINDING UP IN THE DRILL TOWER. COULD NOT USED. HAD TO USED A DIFFERENT SET OF DRILL AND TOWER.

  Patient problems: Not Applicable

  MAUDE report 8529204 ↗
• MalfunctionApr 27, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT THE DRILL SHAFT DID NOT FIT INTO TOWER PROPERLY, PRODUCING METAL SHAVINGS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468145 ↗
• MalfunctionMar 16, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DRILL WON'T FIT THROUGH THE TOWER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7346178 ↗
• MalfunctionMar 2, 2018Device Issue; Device Issue

  SALES REP REPORTS THAT SURGEON ENCOUNTERED ISSUES WITH 2 ATTUNE PRODUCTS, DURING THE PREPARATION OF THE TIBIAL KEEL. THE BIT GOT STUCK INTO THE GUIDE CHIMNEY. NO PATIENT IMPACT. ONLY 2 MINUTES OF DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310160 ↗