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AESCULAP FO530RRecalls & reported problems

Aesculap AG · STILLE Bone Rongeur, angled to side, 9" (230 mm), double action · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653047772), received between May 19, 2021 and May 19, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 19, 2021Material Fragmentation; Material Fragmentation

    NO CHANGES REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11849343 ↗
  • InjuryMay 19, 2021Fracture; Fracture

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FO530R-STILLE BONE RONGEUR230MM AS PER INFORMATION RECEIVED VIA MW (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE RONGEUR BROKE DURING A TOTAL SHOULDER SURGERY. A SCREW BROKE IN HALF AND WAS RECOVERED FROM OPERATIVE WOUND. NO RETAINED FOREIGN BODIES ON X-RAY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11848740 ↗

Other RONGEUR devices

All RONGEUR devices →

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