NA 324.174Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982191151), received between Jul 30, 2019 and Sep 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WIRE SLEEVE IS NOT THREADING INTO PLATE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172440 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WIRE SLEEVE IS NOT THREADING INTO PLATE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171864 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM COLUMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE GUIDEWIRE THREADS ARE WORN AND IT WAS DIFFICULT TO THREAD INTO THE PLATE. QUANTITY OF DEVICE WAS DETERMINED UPON RETURN FOR MANUFACTURER INVESTIGATION. UPON INVESTIGATION, IT WAS DETERMINED THAT ONE GUIDEWIRE HAD A WORN CONDITION OBSERVED AT THE THREADS. THIS REPORT IS FOR A 2.5MM WIRE GUIDE FOR 5.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690215 ↗
• MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT HIGH TIBIAL OSTEOTOMY(HTO) SURGERY WITH THE CLHS. THE SURGEON COMPLAINED THAT IT WAS DIFFICULT TO ATTACH THE GUIDE WIRE TO THE PLATE AND AS WELL THE CLHS GUIDE WIRE WAS MORE DIFFICULT TO USE THAN THE PREVIOUS SLEEVE. THE SURGEON ALSO SAID THAT THE DRIVER SHAFT WAS LONG AND DIFFICULT TO USE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.5MM WIRE GUIDE FOR 5.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452031 ↗
• MalfunctionFeb 2, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286673 ↗
• MalfunctionJul 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREWDRIVER COULD NOT BE INSERTED INTO HEX. NO OTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR ONE (1) 2.5 MM WIRE GUIDE FOR 5.0 MM SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842254 ↗