ELAN 4 GP569RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964776083), received between Feb 3, 2021 and Mar 2, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 2, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GP569R -SHANK LONG F/RECIP.SAW BL.GC615R/GC633R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BREAK OCCURRED DURING THE USE. ALL THE PART WERE REMOVED. THERE IS NO CONSEQUENCE FOR THE PATIENT. THEY ONCE AGAIN ENCOUNTERED A PROBLEM WITH A SAW BLADE HOLDER WHEN IT WAS STERILISED IN A BAG. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399290 ↗
• InjuryFeb 3, 2021Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT A SHANK LONG FOR RECIPROCATING SAW BLADE (PART # GP569R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, A PIECE OF METAL BROKE AWAY AND DETACHED INTO THE PATIENT. THE FRAGMENT WAS RECOVERED FROM THE PATIENT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE INTERVENTION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276326 ↗