ATTUNE 2545-05-517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295491460), received between Nov 8, 2018 and Sep 27, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 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 15495334 ↗
• MalfunctionNov 8, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  BALANCING INSTRUMENTS ARE HAVING TOO MUCH PLAY.

  Patient problems: Not Applicable

  MAUDE report 8051581 ↗