USS 03.607.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034712901), received between Jun 25, 2020 and Oct 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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.

• MalfunctionOct 3, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PLANNED REMOVAL CASE, THE SURGEON WAS USING THE STICK TO REMOVE THE NUT. WHILE TWISTING, IT WAS NOTED THAT THE STICK BROKE ALONG THE SHAFT. A PIECE OF THE SHAFT BROKE OFF, AND ALL PIECES WERE RETRIEVED AND THROWN OUT. THE CASE WAS COMPLETED WITH ANOTHER STICK, AND THE SCREW THAT WAS REQUIRED TO BE REMOVED WAS SUCCESSFULLY REMOVED WITHOUT HARM TO THE PATIENT. THERE WAS NO DELAY AS A RESULT OF THIS EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE HANDLE F/POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527769 ↗
• MalfunctionJun 25, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT A CUSTOMER REQUESTED INFORMATION REGARDING THE RE-PROCESSING OF FERROZELL HANDLES. IT WAS RECOMMENDED TO WASH FERROZELL/PLASTIC HANDLES AT PH 4-9.5. IT IS ALSO RECOMMENDED MILD ALKALINE WASHING AT PH 10.5 - 11.0. THE CUSTOMER CANNOT REPROCESS THE INSTRUMENTS DUE TO COLOR RESIDUES BEING LEFT BEHIND. THIS REPORT INVOLVES ONE (1) HANDLE F/POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10196990 ↗