AESCULAP NF771RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653114535), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 17, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A BIPOLAR CUP HANDLE F/TRIAL HEADS CVD (PART # NF771R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE TIP OF THE TRIAL HANDLE BROKE DURING SURGERY. DURING SURGERY, THE TIP OF THE NF770R DEVIATED FROM THE HANDLE BODY. SINCE THIS EVENT OCCURRED WHEN THE NF770R WAS INSTALLED IN THE BIPOLAR CUP TRIAL, THE TIP REMAINED INSIDE THE CUP. THE REMAINED BIPOLAR CUP WAS CLOSE TO THE PLANNED SIZE, SO THE DOCTOR REMOVED THE TIP PART AND TRIED TO USE IT, BUT COULD NOT REMOVE IT. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING ANOTHER SIZE DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00060 ((B)(4) NF771R). 9610612-2022-00004 ((B)(4) NF770R). INVOLVED COMPONENTS: NG094 - BIPOLAR CUP TRIAL HEAD (B)(4)- LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793299 ↗