ATTUNE 2545-05-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295491453), received between Nov 8, 2018 and Sep 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON INFORMED VIA EMAIL THAT HE FELT HIS MTO IM DRILL GUIDE POSITIONS THE IM HOLE TOO LOW FOR LARGER PATIENTS, SO THAT ON A SIZE 9 AND 10 BALANCE BLOCK, THERE IS NOT ENOUGH EXCURSION OF THE THREADED KNOB BEFORE IT DISENGAGES. IT IS NOT CLEAR WHETHER THIS EVENT IS A DIRECT OBSERVATION FROM SURGERY, OR SOMETHING THAT WAS NOTICED OUTSIDE OF SURGERY ON A FOAM BONE. NO PATIENT HARM IS NOTED AS UNCLEAR IF PATIENT INVOLVED. NOTE ¿ FROM THE DESCRIPTION, THIS WOULD APPEAR TO BE AN OBSERVATION BASED ON THE DESIGN RATHER THAN SOMETHING THAT IS BATCH OR LOT SPECIFIC. THERE IS NO INFORMATION ON HOW MANY ITEMS ARE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495221 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT THE THREAD IN THE ATTUNE BALANCE KNOB IS BROKEN. THE BALANCE BLOCK PIVOT COULD NOT BE THREADED INTO THE KNOB. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, 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, (B)(4). 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 13802501 ↗
• MalfunctionFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent

  THE THREAD INSIDE THE ATTUNE BALANCING BLOCK KNOB IS DAMAGED AND NEEDS REPLACING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758859 ↗
• MalfunctionFeb 26, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE BALANCING BOLT IS STRIPPED THREADS AND PINDRIVER DOES NOT SEAT IN POWER CHUCK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371359 ↗
• MalfunctionNov 8, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  BALANCING INSTRUMENTS ARE HAVING TOO MUCH PLAY.

  Patient problems: Not Applicable

  MAUDE report 8051554 ↗