NA 03.037.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982070197), received between Feb 17, 2021 and Sep 6, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.

• MalfunctionSep 6, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2024, THE DRILL BIT WAS NOT SHARP ENOUGH FOR HARD BONE. THE SURGEON USED ANOTHER DRILL BIT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157180 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT ON OCTOBER 18, 2023 WHEN USING THE OPENING REAMER, IT BROKE OFF AT THE SITE WHERE YOU CHUCK IT UP, RENDERING IT UNABLE TO BE USED. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. A FLEXIBLE OPENING REAMER WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 16MM CANNULATED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074381 ↗
• MalfunctionOct 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(64) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, DURING THE PROXIMAL DRILLING OF THE FEMUR, THE SPECIALIST NOTICED THAT THE 16MM CANNULATED DRILL BIT WAS VERY DIRTY AND FULL OF BONE THAT HAD PLUGGED INTO IT. THE SURGERY WAS DELAYED FOR TWENTY (20) MINUTES AS SURGEON HAD TO REPLACE THE DRILL AND CHANGE THE OLIVE GUIDE. THEN SURGEON STARTED WITH A DRILLING HEAD Ø14 MM TO THE PROXIMAL PART OF THE NAIL, TO THEN DRILL THE REST OF THE CANAL AND VERY CAREFULLY INTRODUCED THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 16MM CANNULATED DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625527 ↗
• InjuryFeb 17, 2021Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE EXTENDED INCISION, THE AIMING ARM DID NOT PROPERLY ALIGN WITH THE DISTAL HOLE OF THE SHORT TFNA NAIL. THE INSTRUMENTATION WAS LOOSE. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11337974 ↗
• InjuryFeb 17, 2021Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE EXTENDED INCISION, THE AIMING ARM DID NOT PROPERLY ALIGN WITH THE DISTAL HOLE OF THE SHORT TFNA NAIL. THE INSTRUMENTATION WAS LOOSE. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11337603 ↗