NA 03.010.229Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982068118), received between Nov 14, 2018 and Jan 22, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, WHILE DRILLING WITH THE 13MM ENTRY DRILL BIT THE SURGEON NOTICED EXTRA RESISTANCE WITHIN THE PROTECTION SLEEVE. WHEN THE DRILL BIT WAS REMOVED THE INSIDE OF THE PROTECTION SLEEVE LOOKED VISIBLY DAMAGED. A PIECE OF METAL HAD BROKEN OFF INSIDE THE CANNULATION OF THE DRILL GUIDE. SURGERY WAS NOT DELAYED. THIS REPORT IS FOR ONE (1) 13MM PROTECTION SLEEVE-SHORT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552226 ↗
• InjuryMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING FEMUR NAIL USING EXPERT RETROGRADE/ ANTEGRADE FEMORAL NAIL (RAFN) INSTRUMENTS. THE SURGEON KEPT PUSHING THE DRILL BIT AND IT HEATED UP THE PROTECTION SLEEVE AND BURNED THE SKIN. BOTH INSTRUMENTS WERE FUNCTIONING NORMALLY AND HAVE BEEN USED SINCE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME BONE FIXATION PROCEEDED AS PLANNED, BUT THE PATIENT HAD SKIN BURN WHICH WAS TREATED AND HEALED AS PLANNED. CONCOMITANT DEVICES REPORTED: 13.0MM CANNULATED DRILL BIT 300MM (PART NUMBER 351.27, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 13MM PROTECTION SLEEVE-SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 10065446 ↗
• MalfunctionNov 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2018, A CANNULATED DRILL BIT BECAME STUCK IN THE GUIDE SLEEVE AND WOULD NOT ROTATE DURING AN UNKNOWN PROCEDURE. BOTH ITEMS WERE REMOVED FROM THE SURGERY. THE NURSE TOOK THEM BACK TO STERILE PROCESSING TO BE CLEANED BY THE TECHNICIAN. AFTER CLEANING, THE DRILL BIT WAS STILL STUCK AND NOT ROTATING. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 13MM PROTECTION SLEEVE-SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8069543 ↗