AESCULAP FF908RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653085545), received between Jun 29, 2021 and Jun 30, 2021 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR DRILL FOR DISTRACTION PINS (PART # FF908R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGICAL PROCEDURE, THE DRILL TIP BROKE OFF IN THE CERVICAL VERTEBRAE. AN X-RAY WITH C-ARM WAS TAKEN TO CONFIRM THAT THE BROKEN DRILL BIT WAS IN THE VERTEBRAL BODY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN BIT FROM THE BONE. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. REPORTEDLY, A SURGICAL DELAY OF APPROXIMATELY TEN (10) MINUTES OCCURRED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096108 ↗
• InjuryJun 29, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR DRILL FOR DISTRACTION PINS (PART # FF908R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGICAL PROCEDURE, THE DRILL TIP BROKE OFF IN THE CERVICAL VERTEBRAE. AN X-RAY WITH C-ARM WAS TAKEN TO CONFIRM THAT THE BROKEN DRILL BIT WAS IN THE VERTEBRAL BODY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN BIT FROM THE BONE. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. REPORTEDLY, A SURGICAL DELAY OF APPROXIMATELY TEN (10) MINUTES OCCURRED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089081 ↗