ATTUNE 2545-05-513Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295481768), received between Feb 5, 2019 and Nov 21, 2025 — classified as 12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. BLACK O RINGS IN FEMORAL POSITIONED WERE PEELING OFF AND IT WAS DISCOVERED UPON CLEANING THE INSTRUMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617824 ↗
• MalfunctionSep 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE STERILIZING DEPARTMENT NOTIFIED US BY EMAIL THAT ONE OF THEIR CONSIGNMENT INSTRUMENTS FROM THE ATTUNE SET, HAD A DAMAGED O RING AND THEY WANTED A REPLACEMENT. NO PATIENT INVOLVEMENT JUST A ROUTINE INSTRUMENT CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937219 ↗
• MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER SEAL NO LONGER STAYS IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS WAS DISCOVERED DURING THE STERILIZATION/INSPECTION PROCESS POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044929 ↗
• MalfunctionMay 5, 2025Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE REAMER SHAFT NO LONGER RETAINED THE REAMER HEAD. SPRING WAS MALFUNCTIONING & CANNOT BE REPAIRED. CR SHIM RUBBER BEARING WAS FRAYED AND COMING LOOSE FROM THE INSTRUMENT. IT WAS NOT SAFE FOR USE ANYMORE.

  Patient problems: Insufficient Information

  MAUDE report 21964119 ↗
• MalfunctionSep 9, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171143 ↗
• MalfunctionAug 13, 2024Naturally Worn; Naturally Worn

  THE INSTRUMENT'S INNER PLASTIC RING IS WORN. SEEN DURING A PRE-OP ROUTINE INSPECTION. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976845 ↗
• MalfunctionJul 8, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT´S INNER PLASTIC RING IS WORN. FRAGMENTS OF THE RING NEEDED TO BE REMOVED DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688671 ↗
• MalfunctionOct 30, 2023Break; Naturally Worn; Unintended Movement; Break; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE ATTUNE CR HORSE SHOE IS BROKEN AND WORN. THE PLASTIC INNER PART OF A HOLE IN THE HORSE SHOE HAS BEEN LOOSENING. CSSD STAFF NOTICED THIS POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18033384 ↗
• MalfunctionSep 16, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE RUBBER LINING IN THE HOLES IS FRAYED AND SMALL BITS OF RUBBER ARE COMING AWAY FROM THE SEAL WHERE THE SHIMS ATTACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438373 ↗
• MalfunctionSep 16, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE RUBBER LINING IN THE HOLES IS FRAYED AND SMALL BITS OF RUBBER ARE COMING AWAY FROM THE SEAL WHERE THE SHIMS ATTACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438371 ↗
• MalfunctionOct 27, 2021Break; Naturally Worn; Break; Naturally Worn

  INSTRUMENTS WERE REPORTED AS BROKEN AND WORN, IDENTIFIED BY STERILIZATION. KITS TAGGED AS BROKEN, CONSIGNMENT, DID NOT OCCUR DURING SURGERY, NO PATIENT AE. BALANCED BLOCK CR SIZER HAS FLAKES IN THE HOLE, SHIMS ARE DAMAGED. SHIMS HAD CHIPS IN THEM, AND STERILE SERVICES WILL NOT STERILIZE AS THEY HAVE QUERIED IF THEY ARE STILL STERILE AFTER STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708789 ↗
• MalfunctionFeb 5, 2019Material Deformation; Material Deformation

  TSU STAFF AT (B)(6) HOSPITAL FOUND THAT ONE OF THE RUBBER RINGS IN THE CR POSITIONER FOR THE RANAWAT BLOCK SHIMS HAD FRAYED. THIS THEN MADE THE PIECE OF EQUIPMENT NOT SAFE TO RE-STERILIZE AND USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304799 ↗