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AESCULAP MF055RRecalls & reported problems

Aesculap, Inc. · DECKER Bone Rongeur, straight, 6" (152 mm), 2 x 6 mm · Class 2

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 04046964202308), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.

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.

  • InjuryApr 28, 2021Break; Break

    IT WAS REPORTED TO AESCULAP INC. THAT A DECKER RONGEURS 2X6MM STR 152MM (PART # MF055R) WAS USED DURING LUMBAR DISCECTOMY AND FORAMINOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SURGEON WAS USING THE INSTRUMENT DURING THE CASE AND THE TIP BROKE OFF AND WAS RETAINED IN THE PATIENT. THERE WAS A 30 MIN DELAY IN THE SURGERY. FURTHER INFORMATION WAS RECEIVED ON APR 13, 2021. ADDITIONAL INTERVENTION WAS REQUIRED, LONGER PROCEDURE TIME AND X-RAY TIME FOR THE SURGEON TO TRY AND RECOVER THE BROKEN PIECE. THE BROKEN PIECE IS STILL IN THE PATIENT. THE PATIENT OUTCOME IS UNKNOWN. THE COMPLAINT DEVICE WAS RETURNED TO MANUFACTURE FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 11739702 ↗

Other RONGEUR, MANUAL 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.