NA 357.394Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982196194), received between Oct 24, 2017 and Nov 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Break; Break

  NO FRAGMENTS REMAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771501 ↗
• MalfunctionFeb 15, 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, ONE (1) 17.0MM CANNULATED DRILL BIT WAS BROKEN. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWENTY (20) MINUTES. THE PROCEDURE WAS COMPLETED USING A NEW DRILL BIT SET. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN POWERTOOL INSTRUMENT (PART: UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 17.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330202 ↗
• MalfunctionNov 23, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT WAS BROKEN AT THE PROXIMAL END. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 17.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886098 ↗
• MalfunctionDec 29, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE. DURING THE PROCEDURE, THE OPENING DRILL BIT SNAPPED AT THE QUICK CONNECT ATTACHMENT. IT WAS CHUCKED ON A STRYKER SYSTEM 7 DRILL. DRILL BIT WAS REMOVED AND THE AWL WAS USED TO COMPLETE ENTRY. GENERATED FRAGMENTS WERE REMOVED EASILY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 17.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7154614 ↗
• MalfunctionOct 24, 2017Break; Break

  IT WAS REPORTED THAT A REAMER BROKE DURING A HIP FRACTURE OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH A TROCHANTERIC FIXATION NAIL (TFN) ON (B)(6) 2017. WHILE OPENING REAMING FOR A FEMORAL NAIL, THE REAMER BROKE WHERE IT WAS ATTACHED TO THE DRILL. THE SURGEON HAD ALREADY GOTTEN DOWN AS FAR AS HE NEEDED TO WHEN THIS OCCURRED. HE THEN REMOVED THE BACKED OUT THE REAMER (NO FRAGMENTS WERE CREATED OR LEFT BEHIND WHEN THE BREAK OCCURRED. THERE WAS NO REPORTED SURGICAL DELAY. NO ADDITIONAL X-RAYS WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR ONE (1) DEVICE. CONCOMITANT DEVICES REPORT: [UNKNOWN FEMORAL NAIL] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND [UNKNOWN STRYKER DRILL] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6973392 ↗