ATTUNE 2544-00-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295130116), received between Sep 24, 2020 and Aug 29, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Crack; Crack

  IT WAS REPORTED THAT THE DEVICE CRACKED DURING IMPACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643355 ↗
• MalfunctionMay 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PROF RECEIVED SOME NEW CUSTOM MADE INSTRUMENTATION YESTERDAY. PRIOR TO CLINICAL USE HE INSPECTED THE KIT AND IT¿S ASSEMBLY WITH OTHER PARTS OF THE INSTRUMENT SYSTEM. NO PATIENTS WERE INVOLVED AS THE INSPECTION WAS CARRIED OUT IN HIS OFFICE. HE REPORTED DIFFICULTY FULLY ASSEMBLING TWO PART OF THE NEW INSTRUMENT KIT WITH ONE PART OF THE EXISTING SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14514559 ↗
• MalfunctionSep 24, 2020Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  ADDITIONAL INFORMATION RECEIVED STATING THAT IT DID NOT OCCUR IN THEATRE, SAWBONES ACTIVITY. PARTS ARE INTACT, NO DAMAGE TO INSTRUMENTS. SURGEON PALM GOT INJURED. JUST THE HANDLE AND SHORT ROD AND NO SERIOUS SURGEON INJURY JUST THE AWARENESS THAT IT COULD HAPPEN.

  Patient problems: Bruise/Contusion; Injury; No Consequences Or Impact To Patient

  MAUDE report 10581674 ↗