NA 03.688.505Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034721552), received between Dec 28, 2022 and Jan 4, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJan 4, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT DURING AN INSPECTION AT LOC UNKRICH IT WAS MENTIONED THAT PERHAPS INCORRECT USE CAUSED A TEAR IN THE RUBBER OF THE HANDLE. NO PATIENT HARM. THIS REPORT IS FOR ONE (1) HANDLE W/RATCHET WRENCH F/QC SM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095153 ↗
• MalfunctionDec 28, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT RATCH HANDLE W/AO QUICK COUPL SM: DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH IT WAS NOTICED THAT THE RUBBER OF THE HANDPIECE COMES OFF. NO SURGERY IMPACT. NO PATIENT IMPACT. SYNFIX® EVOLUTION AIMING DEVICE HOLDER: DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH IT WAS NOTICED THAT INNER SHAFT RUNS TOO 'HEAVY. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) HANDLE W/RATCHET WRENCH F/QC SM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062634 ↗