NA 03.113.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982072887), received between Sep 29, 2020 and Mar 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionMar 22, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BUSH WAS DAMAGED SO IT DID NOT FIT ON THE PLATE. THERE WAS NO PATIENT CONSEQUENCE, AND THE OR WAS NOT AFFECTED BY THIS. THIS CAME FROM A LOANER SET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.6MM PERCUTANEOUS THREADED WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590405 ↗
• MalfunctionSep 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIAL PLATEAU CASE ON (B)(6) 2020, THE UNKNOWN AIMING ARM AND THE 1.6 MM THREADED WIRE GUIDE WAS FUSED TOGETHER WITH THE HANDLE FOR DRILL SLEEVES AND COULD NOT BE ABLE TO GET THOSE PIECES APART WHICH EACH OTHER. THE ISSUE CAUSED A SMALL DELAY TO THE PROCEDURE. ANOTHER DEVICE WAS USED ON THE CASE. PATIENT STATUS AND SURGICAL OUTCOMES WAS SUCCESSFUL. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 1.6MM PERCUTANEOUS THREADED WIRE GUIDE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10600027 ↗