INSTRUMENT 6541-4-809Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327179293), received between Jun 9, 2017 and Sep 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionSep 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT IT SEEMS HARD TO GET THE PIN INTO 2 HEADLESS DRIVERS. IT SEEMS LIKE THE RUBBER MEMBRANE INSIDE IS TOO HARD AND YOU HAVE TO PUSH AND TURN QUITE HARD TO PENETRATE THE MEMBRANE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902631 ↗
• MalfunctionJun 9, 2017Device Operates Differently Than Expected

  REPORTER STATED THAT THE RUBBER MEMBRANE INSIDE THIS PINDRIVER SEEMS TO BE DIFFICULT TO PENETRATE WITH A PIN. PREVIOUS EXPERIENCE INCLUDED HAVING TO ROTATE THE PIN 2 MM TO GET IT IN PLACE. THIS PINDRIVER IT IS HARD TO DO SO. THE PIN WILL ONLY IN 10% OF THE TIMES GET IN THE RIGHT POSITION. PATIENT NOT AFFECTED, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6632073 ↗