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AESCULAP ME246RRecalls & reported problems

Aesculap, Inc. · Inserter Shaft · 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 04046964985119), received between Aug 10, 2021 and Aug 10, 2021 — 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

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionAug 10, 2021Break; Break

    IT WAS REPORTED TO AESCULAP INC. THAT A INSERTER SHAFT (PART # ME246R) WAS USED DURING TOTAL DISC REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, INSTRUMENT BROKE DURING SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 12303014 ↗

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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.