Skip to content

NA 219435Recalls & reported problems

Depuy Mitek, LLC · ANTEROMEDIAL OFFSET AIMER 4.5mm · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705006427), received between Mar 20, 2023 and Mar 20, 2023 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 20, 2023Break; Break

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN PORTUGAL THAT THE ANTEROMEDIAL OFFSET AIMER, 4.5MM DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16575859 ↗

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.