NA 03.605.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034712338), received between Apr 12, 2021 and Sep 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AUG 22, 2024 THE REPORTER IDENTIFIED THAT THE INSTRUMENT BROKE. THERE WAS NO INDICATION THAT THERE WAS AN ADVERSE EVENT AS THE RESULT OF THIS INSTRUMENT MALFUNCTION. THERE WAS NO INDICATION THAT THE SURGICAL PROCEDURE WAS DELAYED DUE TO THIS MALFUNCTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189551 ↗
• MalfunctionDec 20, 2022Contamination /Decontamination Problem; Compatibility Problem; Contamination /Decontamination Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: DURING THE CLEANING PROCESS IT WAS MENTIONED THAT THE PUNCHES AND RONGEURS TO A PROPER AND SUCCESSFUL CLEANING, BUT IT WAS NOT POSSIBLE TO ELIMINATE VISIBLE CONTAMINATION. THE PROBLEM WITH THE DRUM TONGS AND RONGEURS IS THAT THEY CAN BE DISMANTLED. OUR DRUM TONGS (RONGEURS) AND PUNCHES OF THIS GENERATION DO NOT ALLOW DISMANTLING (DISMANTLING FOR PROPER CLEANING IN THE AEMP). DESPITE REPEATED ATTEMPTS WITH MANUAL PRE-CLEANING, ULTRASOUND CLEANING AND SUBSEQUENT MECHANICAL CLEANING AND DISINFECTION, DETECTABLE BLOOD RESIDUES REMAIN ON THE SURFACES VIA HEMOCHECK-S. NO PATIENT HARM. NO SURGERY DELAY. THIS REPORT IS FOR ONE (1) RONG STRAIG W/4 L330. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019057 ↗
• MalfunctionApr 19, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE TIP OF THE DISC RONGEUR BROKE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM WIDTH 330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688710 ↗
• MalfunctionApr 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE DISC RONGEUR STRAIGHT WITHOUT TEETH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649666 ↗