ATTUNE 2506-30-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295477846), received between Oct 14, 2019 and Nov 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionNov 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION RECEIVED FROM ORTHOKIT: A. VALID DSI YES/NO NO. B. COMMENTS WHY JUSTIFIED OR NOT JUSTIFIED: WE COULD NOT SEE THAT THE ITEMS ARE DIRTY IN THE PICTURES FROM CUSTOMER. MAJA, YOU MENTIONED THAT THIS CUSTOMER IS QUITE STRICT AND IF THE FIND ANY SINGLE SPOT THEY MAY THINK ITEMS ARE DIRTY. THIS MODULE WERE WASHED BY PREVIOUS CUSTOMER AND WE COULD NOT SEE ANY DIRT DURING OUR PREVIOUS INSPECTION. AFTER A COUPLE OF WASHES THE INSTRUMENTS WILL TEND TO HAVE STAINS BUT THAT DO NOT MEAN THAT INSTRUMENTS ARE CONTAMINATED OR DIRTY, INSTRUMENTS CANNOT LOOK NEW ALL THE TIME. C. ACTION TAKEN BY ORTHOKIT OPERATIONS: ITEMS INSPECTED AND WE COULD NOT SEE ANY DIRT. NO MORE ACTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145219 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT. NASHVILLE LOANER SET 4 - GENERAL FEMORAL PREP. APPEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9185006 ↗