NA 357.407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982196309), received between Apr 17, 2020 and Mar 16, 2021 — classified as 1 injury, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE TWO (2) DRILL BITS BROKE DURING THE PROCEDURE. THE FRAGMENTS WERE LEFT IN THE PATIENT WITHOUT ANY COMPLICATIONS. THIS REPORT IS FOR ONE (1) 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11496989 ↗
• MalfunctionMar 2, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL BIT BROKE. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: DRILL: (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398878 ↗
• MalfunctionJul 2, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SURGERY THE TFN EQUIPMENT WAS HAVING DIFFICULTY REVERSING AND THE DRILL BIT BROKE IN THE DISTAL LOCK. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224148 ↗
• MalfunctionApr 17, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE A DRILL BIT WOULD NOT DRILL/CUT APPROPRIATELY. PATIENT STATUS AND SURGICAL DELAY IS UNKNOWN THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971963 ↗