NA 357.430Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982196477), received between Jun 21, 2017 and Oct 18, 2021 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, A TAP/REAMER FOR TFN SCREW WAS USED WITH AN UN ALLEGATION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651335 ↗
• MalfunctionOct 25, 2019Break; Break

  LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE REAMER FOR TROCHANTERIC FIXATION NAIL SCREW WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9240288 ↗
• MalfunctionMay 18, 2018Break; Break

  IT WAS REPORTED THAT THE HANDLE TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW BROKE DURING A PROCEDURE ON (B)(6) 2018. THERE WAS NO DELAY IN SURGERY AND ALL PARTS WERE RETRIEVED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525026 ↗
• MalfunctionFeb 2, 2018Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE OFF THE TAP FOR THE LAG SCREW. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238626 ↗
• MalfunctionJul 13, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAILING FOR A LEFT INTERTROCHANTERIC FRACTURE ON (B)(6) 2017, THE SURGEON WAS USING THE TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW TO MAKE A PATH FOR THE TROCHANTERIC FIXATION NAIL SCREW THREADS, WHEN THE HANDLE TO THE TAP/REAMER BROKE. THE TAP/REAMER WAS HALFWAY IN THE PATIENT WHEN THE BREAKAGE OCCURRED. THERE WERE NO FRAGMENTS FROM THE BREAKAGE. A PAIR OF COMPETITOR'S VICE GRIPS WAS USED TO GRAB THE SHAFT OF THE TAP/REAMER WHERE THE BREAKAGE OCCURRED AND THE SURGEON WAS ABLE TO BACK OUT THE TAP/REAMER WITHOUT INCIDENT. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY TO OBTAIN THE VICE GRIPS AND REMOVE THE BROKEN TAP/REAMER. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. ALTHOUGH THE HANDLE TO THE TAP/REAMER BROKE WHILE HALFWAY IN THE PATIENT, THE SURGEON WAS ABLE TO PREPARE THE CORRECT PATHWAY FOR INSERTION OF THE TROCHANTERIC FIXATION NAIL SCREW. THERE WAS NO PATIENT HARM. THE PATIENT WAS REPORTED AS STABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: BLADE GUIDE SLEEVE (PART 357.369, LOT NUMBER UNKNOWN, QUANTITY 1), GUIDE WIRE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711227 ↗
• MalfunctionJun 21, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING HIP NAILING TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SURGERY ON (B)(6) 2017, THE SET SCREW WAS TOO DEEP IN THE NAIL THEREFORE THE FEMORAL NECK SCREW COULD NOT PASS THROUGH THE HOLE. SO SURGEON TRIED TO PASS IT WITH THE TAP. THE TAP BROKE INTRA-OPERATIVELY. THE SURGEON REMOVED THE NECK SCREW AND USED ANOTHER ONE, THE NAIL IS STILL IN THE PATIENT. THE SURGERY WAS PROLONGED ABOUT 45 MINUTES. PATIENT CONDITION AFTER THE SURGERY WAS STABLE. THERE WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6656964 ↗