PLASMAFIT NT419RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964093487), received between Jun 6, 2023 and Jun 7, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP INC. THAT A FLEXIBLE SHAFT F/DRILL BITS (PART # NT419R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHAFT BROKE WHILE DRILLING BONE. THE SHAFT BROKE INTO TWO (2) PIECES; ONE (1) PIECE REMAINED ATTACHED TO THE DRILL, WHILE THE OTHER DETACHED INTO THE PATIENT. THE SEPARATED SECTION WAS REMOVED FROM THE PATIENT WITH THE DRILL BIT INTACT. THE FLEXIBLE SHAFT WAS THE ONLY PART THAT WAS BROKEN. NO BACKUP DEVICE WAS AVAILABLE, SO THE PHYSICIAN PROCEEDED A BACKUP DEVICE WAS NOT AVAILABLE, SO THE SURGEON HAD TO PUSH REALLY HARD UNTIL HE GOT A BITE IN THE BONE WHICH ALLOWED THE SCREW TO SELF-TAP INTO THE BONE. REPORTEDLY, THE DEVICE WAS BEING USED AS INTENDED. ALTHOUGH THE DOCTOR MAY HAVE BEEN A LITTLE ROUGH WITH IT, NO OTHER OCCURRENCES WERE OBSERVED DURING THE APPROXIMATE TWENTY (20) TO THIRTY (30) PRIOR CASES WHERE THIS DEVICE WAS USED. ALTHOUGH AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17077790 ↗
• InjuryJun 6, 2023Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A FLEXIBLE SHAFT F/DRILL BITS (PART#: NT419R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHAFT BROKE WHILE DRILLING BONE. THE SHAFT BROKE INTO TWO (2) PIECES; ONE (1) PIECE REMAINED ATTACHED TO THE DRILL, WHILE THE OTHER DETACHED INTO THE PATIENT. THE SEPARATED SECTION WAS REMOVED FROM THE PATIENT WITH THE DRILL BIT INTACT. THE FLEXIBLE SHAFT WAS THE ONLY PART THAT WAS BROKEN. NO BACKUP DEVICE WAS AVAILABLE, SO THE PHYSICIAN PROCEEDED A BACKUP DEVICE WAS NOT AVAILABLE, SO THE SURGEON HAD TO PUSH REALLY HARD UNTIL HE GOT A BITE IN THE BONE WHICH ALLOWED THE SCREW TO SELF-TAP INTO THE BONE. REPORTEDLY, THE DEVICE WAS BEING USED AS INTENDED. ALTHOUGH THE DOCTOR MAY HAVE BEEN A LITTLE ROUGH WITH IT, NO OTHER OCCURRENCES WERE OBSERVED DURING THE APPROXIMATE TWENTY (20) TO THIRTY (30) PRIOR CASES WHERE THIS DEVICE WAS USED. ALTHOUGH AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073628 ↗