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AESCULAP MG509RRecalls & reported problems

Aesculap, Inc. · ANKENEY STERNAL RETR.SET W/6 BLD.35X35MM · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955057207), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (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

  • Mechanical Jam1

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.

  • InjuryJun 9, 2021Mechanical Jam; Mechanical Jam

    IT WAS REPORTED TO AESCULAP INC. THAT A ANKENEY STERNAL RETR.SET W/6 BLD.35X35MM (PART # MG509R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CRANK HANDLE BECAME STUCK AND WAS NOT ABLE TO BE TURNED WHILE INSIDE THE PATIENT. THE HANDLE WAS FORCIBLY TURNED USING A MALLOT, WHICH RESULTED IN THE CREATION OF METAL SHAVINGS. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11970563 ↗

Other RETRACTOR devices

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