ATTUNE 2544-00-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295421078), received between Mar 21, 2019 and Apr 28, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SLOT FOR SAW IS DENTED. THERE WAS NO PATIENT AFFECTED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918744 ↗
• MalfunctionFeb 19, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN HOLE WRAPPED, IT DOES NOT SLIDE OVER PIN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411660 ↗
• MalfunctionFeb 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT CUT SLOT IS DAMAGED AND METAL IS BENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297363 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IN STUCK IN THE GUIDE. SURGERY DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720415 ↗
• MalfunctionJul 3, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT BROKEN PIN WOULDN'T FREE FROM CUTTING BLOCK. CHECK AGAINST OTHER PINS THIS REVEALED THAT NONE OF THE PINS WOULD FIT CORRECTLY AND LIKELY THE METAL HOLE HAD PERHAPS WARPED OUT OF SHAPE AND WOULD NOT FUNCTION CORRECTLY. THE SAME PINS WERE COMPARED TO THE RIGHT CUTTING BLOCK ON THIS TRAY AND PERFORMED AS INTENDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664512 ↗
• MalfunctionJun 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ITEM HAS A DAMAGED PIN HOLE, MAKING IT UNUSABLE. IT WAS NOTICED DURING KIT INSPECTION BY STERILE SERVICES AND NOT DURING SURGERY, THEREFORE NO IMPACT TO PATIENT OR SURGERY HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475148 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ONE OF THE PIN HOLES ON THE BLOCK IS TOO NARROW FOR THE PIN TO PASS THROUGH. NO FURTHER ACTION NEEDED, NO EXTENSION TO SURGERY AND NO NEGATIVE OUTCOME FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159774 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTATION WAS LOOSE. DISTAL FEMORAL CUT BLOCK FELT LOOSE ON THE DISTAL FEMORAL JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866596 ↗
• MalfunctionJan 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SPRING BROKEN PREVENTING SHIMS FROM STAYING ON THE FLEXION/EXTENSION GUIDE. NO IMPACT TO PATIENT OR SURGERY ¿ NOTICED DURING CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520030 ↗
• MalfunctionNov 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LEFT TIBIA CUT BLOCK IS WORN OUT. REJECTED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215308 ↗
• MalfunctionOct 30, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PIN STUCK AND BROKE OFF IN HOLE, MAY HAVE BEEN A BURR IN THE FIXATION HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035575 ↗
• MalfunctionApr 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL ALIGNMENT HANDLE KEEPS STICKING IN THE TIBIAL CUTTING BLOCK. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831841 ↗
• MalfunctionOct 18, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE ATTUNE TIBIAL IMPACTOR WAS BROKEN BY SURGEON DURING IMPACTION. THE CUTTING SLOT HAS NARROWED AND CAUSED THE TIBIAL STYLUS TO GET STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625288 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  LOAN KIT INSTRUMENTS. LEFT TIBIAL CUTTING BLOCK HAS A BURRED HOLE SO IT CANT BE ATTACHED TO THE TIBIAL JIG. DISTAL JIG RED ACTUATOR WHICH ATTACHES THE DISTAL BLOCK WAS ALSO BENT AND BLOCK WAS UNABLE TO BE ATTACHED TO THE DISTAL JIG. WE ENDED UP USING THE SYMMETRICAL BLOCK FOR THE TIBIAL JIG SO IT WAS ABLE TO BE USED. DR BENT THE RED ACTUATOR BACK INTO PLACE AND WE WERE ABLE TO GET THROUGH THE CASE. CASE COMPLETED SUCCESSFULLY AND NO IMPACT TO PATIENT. MINIMAL TIME DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064754 ↗
• MalfunctionMay 26, 2022Scratched Material; Scratched Material

  THE TIBIAL CUTTING BLOCK IS NICKED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516912 ↗
• MalfunctionApr 28, 2022Break; Break

  THE HOSPITAL HAVE REPORTED A BROKEN ATTUNE INSTRUMENT. ABLE TO COMPLETE THE CASE WITHOUT AFFECTING PATIENT OUTCOME AND SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240117 ↗
• MalfunctionMar 17, 2022Material Deformation; Material Deformation

  TRIAL POST IS BROKEN. THERE IS A PIECE OF METAL STICKING OUT OF THE LEFT TIBIA CUTTING BLOCK. THERE IS A PIECE OF METAL STICKING OUT OF THE RIGHT TIBIA CUTTING BLOCK AS WELL, BUT IT WAS DISCOVERED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802196 ↗
• MalfunctionJul 9, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUTTING BLOCK GOT LOST IN THE POST-OP/DECONTAMINATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145425 ↗
• MalfunctionJun 18, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE CUT BLOCK FOR LEFT IN QUESTION. BEFORE THE SURGERY, THERE SEEMED TO BE CRACKS IN THIS CUT BLOCK, AND THE PASSAGE OF THE BLADE WAS POOR, AND IT WAS DIFFICULT TO FIT THE ALIGNMENT HANDLE. SINCE IT WAS NOTICED AT THE STAGE OF PREPARATION, IT WAS CHANGED TO THE BLOCK FOR RIGHT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12027251 ↗
• MalfunctionMay 26, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR LEFT OA. DURING THE SURGERY, WHEN THE SURGEON PERFORMED AN OSTEOTOMY WITH THE INSTRUMENTS, A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED, AND THE BONE STAINED BLACK. THE SURGEON SUSPECTED THAT THE MATERIAL HAD CHANGED AND COMMENTED THAT THE MATERIAL OF THE INSTRUMENTS HAD BECOME LESS EXPENSIVE. WHEN AN OSTEOTOMY WAS PERFORMED WITH A NOTCH GUIDE, AN OSTEOTOMY WAS PERFORMED WITH A RECIPROCATING SAW, BUT THE METAL PART WAS SEVERELY ABRADED. ALSO, THE PRECISION OF THE SLIT SEEMED TO BE POOR, AND A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED. THE SURGEON USED A 1.19 MM BLADE. THE CLEARANCE WITH THE SLIT WAS LARGE, AND THE SURGEON ALSO OPERATED NOT TO TOUCH THE SLIT. THE SURGEON STATED THAT EVEN A NEW INSTRUMENT DID NOT DO THIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890311 ↗
• MalfunctionMar 30, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENT WAS SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592599 ↗
• MalfunctionJan 29, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE ATTUNE 0 DEGREE LEFT TIBIA CUTTING BLOCK WAS NICKED BY THE SAW ON THE MEDIAL EDGE OF THE CUTTING SLOT CAUSING A SHARP PROTRUSION. NO PATIENT INVOLVEMENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252106 ↗
• MalfunctionDec 16, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TIBIAL LEFT CUTTING BLOCK HAD A ROUGH PLACE FROM THE SAW BLADE ON THE MEDIAL SIDE OF BLOCK. THIS COULD RIP GLOVES AS IT WAS PASSED. THEY RETURNING, NO ONE WAS INJURED, SURGERY WAS NOT DELAYED. THEY HAD 2 ARTICULAR SURFACE PIECES THAT WAS BROKEN, UNFORTUNATELY THIS DID HAPPEN IN SURGERY, THEY WERE MISTAKENLY DISPOSED OF DURING WASH CYCLE, DO NOT HAD THESE TO RETURN. SURFACE PIECES RACKED IN 2 PIECES, THIS DID NOT DELAY SURGERY, NO ONE WAS INJURED AND NOT RETURNING THESE, AS THEY NEVER APPEARED AFTER WASH. THEY HAD PICTURES OF EACH ITEM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020845 ↗
• MalfunctionJul 14, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HOLES OF THE BLOCK THAT CONNECT TO THE JIG ARE WARPED OR PINCHED. THE BLOCK GETS STUCK ON THE TIBIA JIGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271079 ↗
• MalfunctionFeb 10, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DURING THE PROCEDURE THE SURGEON HAS DIFFICULTY INSERTING THE SAW BLADE INTO THE CUTTING SLOT. THE CUSTOMER SAID IT APPEARS TO BE BENT. HE MANAGED TO GET IT IN, IN THE END, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9689116 ↗