NA 324.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982191199), received between Oct 13, 2021 and Apr 18, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE ON (B)(6) 2023, THE SURGEON WAS THREADING THE H&LE FOR PERCUTANEOUS THRD DRILL GUIDES INTO THE THREADED DRILL GUIDES, AND THE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES WOULD THREAD BUT NOT RETAIN THE RIGIDNESS THAT THE SURGEON WAS USED TO ACHIEVING. THE SURGERY WAS DELAYED BY FOUR MINUTES DUE TO THE EVENT. A SECOND SET OF INSTRUMENTS WAS OPENED IN ORDER TO OBTAIN ANOTHER PERCUTANEOUS THREADED DRILL GUIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.2MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762245 ↗
• MalfunctionOct 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE THREADED GUIDES FOR THE 4.5 LCP AIMING ARM HAVE BEEN REPLACED. THE 4.0MM HEX WRENCH THAT HAS TYPICALLY BEEN USED TO TIGHTEN/LOOSEN THE GUIDES FROM THE PLATE WILL NOT BE ACCEPTED NOW. UPON INSPECTION, THE DIAMETER OF THE PROXIMAL HOLES ARE SMALLER THAN THE GUIDES THAT WERE REPLACED. THIS REPORT IS FOR ONE (1) 3.2MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625196 ↗
• MalfunctionOct 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE THREADED GUIDES FOR THE 4.5 LCP AIMING ARM HAVE BEEN REPLACED. THE 4.0MM HEX WRENCH THAT HAS TYPICALLY BEEN USED TO TIGHTEN/LOOSEN THE GUIDES FROM THE PLATE WILL NOT BE ACCEPTED NOW. UPON INSPECTION, THE DIAMETER OF THE PROXIMAL HOLES ARE SMALLER THAN THE GUIDES THAT WERE REPLACED. THIS REPORT IS FOR ONE (1) 3.2MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625168 ↗
• MalfunctionOct 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE THREADED GUIDES FOR THE 4.5 LCP AIMING ARM HAVE BEEN REPLACED. THE 4.0MM HEX WRENCH THAT HAS TYPICALLY BEEN USED TO TIGHTEN/LOOSEN THE GUIDES FROM THE PLATE WILL NOT BE ACCEPTED NOW. UPON INSPECTION, THE DIAMETER OF THE PROXIMAL HOLES ARE SMALLER THAN THE GUIDES THAT WERE REPLACED. THIS REPORT IS FOR ONE (1) 3.2MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625150 ↗
• MalfunctionOct 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE THREADED GUIDES FOR THE 4.5 LCP AIMING ARM HAVE BEEN REPLACED. THE 4.0MM HEX WRENCH THAT HAS TYPICALLY BEEN USED TO TIGHTEN/LOOSEN THE GUIDES FROM THE PLATE WILL NOT BE ACCEPTED NOW. UPON INSPECTION, THE DIAMETER OF THE PROXIMAL HOLES ARE SMALLER THAN THE GUIDES THAT WERE REPLACED. THIS REPORT IS FOR ONE (1) 3.2MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624989 ↗