NA 03.037.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982070203), received between Feb 8, 2019 and May 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Deformation

  IT WAS REPORTED THAT THE TEETH ON HOLLOW DRILL BIT ARE BENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095782 ↗
• MalfunctionJul 17, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE METAL SLIDE OF REAMER WOULD NOT CLICK INTO THE TOP PORTION AND REMAIN LOCKED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332889 ↗
• MalfunctionDec 8, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING STERILE PROCESSING THE CANNULATED HOLLOW DRILL BIT WAS MISSING THE RETENTION PIN. AS A RESULT, THE SLIDING PIECE WILL NOT STAY IN POSITION. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THAT THE LASER WELD TO SECURE THE SPRING COMPONENT TO THE CENTERING ATTACHMENT WAS BROKEN. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970398 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE LOCKING CLIP ON THE 16MM HOLLOW REAMER WAS MISSING THE RETENTION PIN ON THE LOCKING CLIP. THIS WAS NOTED BY STERILE PROCESSING PERSONNEL DURING SET ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10220650 ↗
• MalfunctionFeb 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE CENTERING SLEEVE BECAME DAMAGED WHILE OPENING BONE FOR A TFNA. ON INSPECTION OF THE INSTRUMENT IT APPEARED THE TINY HOLDING PIN HAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659676 ↗
• MalfunctionFeb 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, A PART OF CANNULATED HOLLOW REAMER FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS NOT CLICKING AND HOLDING AND THEREFORE IT WAS NOT USABLE. ANOTHER CANNULATED HOLLOW REAMER FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS WORKING FINE. THE DEVICE WAS NOT NEEDED FOR SURGERY WHEN THE FAULT WAS DISCOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322824 ↗