NA 395.911Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982200891), received between Sep 17, 2021 and Oct 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 21, 2023, THE PATIENT UNDERWENT A TEMPORARY EXTERNAL FIXATION FOR AN ANKLE FRACTURE. WHILE DRILLING THE TIBIAL USING THE SELDRILL WITH THE SLEEVE, THE SELDRILL STOPPED ADVANCING. SINCE THE INSERTION DEPTH WAS SHALLOW, THE SELDRILL AND SLEEVE WERE ABLE TO BE REMOVED, AND THE SURGEON CONTINUED THE OPERATION WITHOUT USING A SLEEVE. THE SELDRILL AND SLEEVE GOT STUCK AND COULD NOT BE DETACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE DRILL SLEEVE HANDLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17903963 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL SLEEVE HANDLE WAS OVERTORQUED AND WAS BENT WHEN INSERTING THE EX FIX SLEEVES. WHILE INSERTING THE TWO STRAIGHT OUTRIGGERS ON THE COMBI CLAMP, IT ALSO WAS OVERTIGHTENED AND WAS STRIPPED. THE MULTI PIN GUIDE FOR THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS STICKING DURING THE CONTRALATERAL FEMUR WAS BEING IMPLANTED. THE HANDLE OF 395.911 WAS USE TO PULL TRACTION AND IT ENDED UP SCREWING UP THE THREADS OF THE HANDLE. A TRIPLE SLEEVE WAS THREADED IN AND WE WERE UNABLE TO THREAD IT IN. THE STRAIGHT OUTRIGGERS WERE BOTH UNABLE TO BE TIGHTENED. THERE WAS A (3) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT CLAMPS. CONCOMITANT DEVICE REPORTED: UNKOWN - EXFIX: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR (1) DRILL SLEEVE HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488874 ↗