NA 312.24Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982187697), received between Apr 4, 2018 and Apr 14, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, IT WAS REPORTED MULTIPLE DEVICES WERE BENT AND HAD FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876982 ↗
• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871345 ↗
• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871342 ↗
• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871338 ↗
• MalfunctionFeb 10, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE PROCESSING, STAFF NOTICED THAT THE DRILL GUIDE WAS BENT AND NO LONGER ACCEPTS THE APPROPRIATE DRILL BIT. THE COUNTERSINK QUICK COUPLING ATTACHMENT NO LONGER FITS TO ITS DESIGNED HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308445 ↗
• MalfunctionFeb 10, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE PROCESSING, STAFF NOTICED THAT THE DRILL GUIDE WAS BENT AND NO LONGER ACCEPTS THE APPROPRIATE DRILL BIT. THE COUNTERSINK QUICK COUPLING ATTACHMENT NO LONGER FITS TO ITS DESIGNED HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308444 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DRILL GUIDE HANDLE WOULD NOT KEY AND BENT ON OCCASIONS. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.7MM/2.0MM DOUBLE DRILL SLEEVE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023348 ↗
• MalfunctionSep 9, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON (B)(6) 2022 THAT THE DRILL GUIDE WAS BENT AND THE DRILL BIT DIDN'T GO THROUGH NICELY. IT IS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT INVOLVES ONE 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390770 ↗
• InjuryFeb 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE LAG SCREW TECHNIQUE, THE 2.0MM DRILL GUIDE WOULD NOT PASS THROUGH THE 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THE SHAFT OF THE DRILL GUIDE HAD BECOME DETACHED FROM THE DRILL GUIDE BASE, WHICH OBSTRUCTED THE DRILL ENTRY. THERE WAS A 30 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME AS PLANNED. THIS COMPLAINT TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375674 ↗
• MalfunctionDec 17, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE ITEMS WERE INVOLVED. ONE 1.5/1.1 DRILL GUIDE BROKE, ONE 2.7/2.0 DRILL GUIDE WAS BROKEN WITH A DRILL BIT COLD WELDED INTO IT, AND A CRUCIFORM SCREWDRIVER HEAD WAS STRIPPED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE STATUS WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR 1 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029149 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DOUBLE DRILL GUIDE BROKE AT THE JUNCTION BETWEEN THE HANDLE AND THE ACTUAL DRILL GUIDE. IT IS UNKNOWN IF THERE WERE A PROCEDURE AND PATIENT INVOLVEMENT. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972156 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING STERILE PROCESSING, THE DOUBLE DRILL SLEEVE TISSUE PROTECTOR WAS FOUND WITH ITS LUMEN DETACHED FROM THE HANDLE WHILE RESETTING SETS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THIS REPORT IS FOR 1 OF 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8333535 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DOUBLE DRILL GUIDE WAS FOUND BROKEN AND SEPARATED FROM ITS TISSUE PROTECTOR HANDLE IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN TISSUE PROTECTOR HANDLE (PART# UNKNOWN, LOT# UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM/2.0MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8081283 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT A DOUBLE DRILL GUIDE IS BROKEN. THIS WAS DISCOVERED BY THE SALES REP WHEN HE WENT TO USE THE DEVICE FROM HIS SET AND SAW THAT IT WAS BROKEN. THE TUBE ON THE 2.0MM SIDE OF THE DEVICE BROKE OFF. ONE PIECE WAS KEPT THE OTHER PIECE WAS DISCARDED. THE DEVICE WAS USED IN A CASE THE DAY PRIOR BUT WHEN THE SALES REP WHO WAS NOT PRESENT IN THE CASE INQUIRED ABOUT WHAT HAPPENED, THE ONLY INFORMATION HE WAS GIVEN WAS THAT THE DEVICE BROKE DURING SURGERY. NO PATIENT OR PROCEDURE INFORMATION KNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397693 ↗