NA 03.043.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982297402), received between Aug 30, 2022 and Nov 3, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE TIP IS CHIPPED AND HAS SCORING. NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457870 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT THE DRILL BIT TIP IS CHIPPED. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422861 ↗
• MalfunctionAug 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR NAIL SURGERY ON (B)(6) 2023, THE SLEEVE WAS TIGHT BECAUSE OF A TIGHT PATELLA FEMORAL JOINT, AND CAUSED THE REAMERS AND DRILL TO BE ¿GRABBED¿. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EVENT OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DRILL BIT / FLEXIBLE / Ø 12MM LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450100 ↗
• MalfunctionJun 23, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2023 THE DRILL IS WORN AND NO LONGER SHARP. PATIENT OUTCOME WERE UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT / FLEXIBLE / 12MM LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190394 ↗
• MalfunctionMar 13, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT; THE TIMING OF THE EVENT WAS POSTOPERATIVE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRILL BIT / FLEXIBLE / Ø 12MM LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529757 ↗
• MalfunctionAug 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT TWO REAMERS FROM THE TIBIAL NAIL ADVANCED BECOME JAMMED IN THE DHS/DCS ATTACHMENT OF UNIUM POWER TOOLS. THERE WAS NO EFFECT ON PATIENT CARE OR OPERATION TIME. THIS REPORT IS FOR A DRILL BIT / FLEXIBLE / Ø 12MM LONG. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331219 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT TWO REAMERS FROM THE TIBIAL NAIL ADVANCED BECOME JAMMED IN THE DHS/DCS ATTACHMENT OF UNIUM POWER TOOLS. THERE WAS NO EFFECT ON PATIENT CARE OR OPERATION TIME. THIS REPORT IS FOR A DRILL BIT / FLEXIBLE / Ø 12MM LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324413 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT TWO REAMERS FROM THE TIBIAL NAIL ADVANCED BECOME JAMMED IN THE DHS/DCS ATTACHMENT OF UNIUM POWER TOOLS. THERE WAS NO EFFECT ON PATIENT CARE OR OPERATION TIME. THIS REPORT IS FOR A DRILL BIT / FLEXIBLE / Ø 12MM LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324360 ↗