NA 314.75Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982189097), received between Feb 5, 2018 and Feb 25, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Contamination /Decontamination Problem

  SCREWDRIVER HANDLE LEAVES A STAIN IN PEEL PACK AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443736 ↗
• MalfunctionAug 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING FIELD INSPECTION/PROCESSING, IT WAS DISCOVERED THAT THE SCREWDRIVER HANDLES ARE LEAVING A STAIN ON THE PEEL PACKS. THERE WERE NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968059 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING PRE-SURGERY, THE SHAFT OF THE SCREWDRIVER IN QUESTION WAS FOUND TO TURN IN THE HANDLE. METAL PIECES ARE LIFTED UP SO THAT HANDS/FINGERS GET CAUGHT. THIS ISSUE WAS DISCOVERED BEFORE THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634490 ↗
• MalfunctionJan 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE INSPECTION THE HEXAGONAL SCREWDRIVER TIP WAS FOUND TO BE ROUNDING OUT AND LOSING HEX SHAPE. THIS REPORT INVOLVES ONE (1) HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228941 ↗
• MalfunctionOct 11, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF NOTICED GREASE IN THE TRAY UNDERNEATH THE SCREWDRIVERS, WHILE PROCESSING THE TROCHANTERIC FIXATION NAIL (TFN) INSTRUMENTS IN MEDICAL DEVICE REPROCESSING (MDR). THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7956595 ↗
• MalfunctionOct 11, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF NOTICED GREASE IN THE TRAY UNDERNEATH THE SCREWDRIVERS, WHILE PROCESSING THE TROCHANTERIC FIXATION NAIL (TFN) INSTRUMENTS IN MEDICAL DEVICE REPROCESSING (MDR). THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7956573 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380064 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380051 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380045 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380033 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380019 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7380005 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2018, IT WAS DISCOVERED THAT THERE WAS A SMALL, THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN (7) HEXAGONAL SCREWDRIVERS. THE DEVICES ARE FROM TWO (2) TROCHANTERIC FIXATION NAIL (TFN) LOCKING TRAYS, TWO (2) TFN INSERTION TRAYS, TWO (2) EXPERT TIBIAL NAIL SETS, AND TWO (2) EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) HEXAGONAL SCREWDRIVER. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7379992 ↗
• MalfunctionFeb 5, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  (B)(4) REPORTED THAT DURING TIBIAL FRACTURE PROCEDURE ON (B)(6) 2018, SCREW DRIVER HEAD WAS FOUND TO BE BROKEN AND WOULDN'T GRIP ENOUGH TO INSERT LOCKING BOLT DURING LOCKING STEPS OF EXPERT NAIL INSERTION. NO PATIENT HARM NOTED. THERE WAS NO DELAY IN PROCEDURE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED AS FINE. CONCOMITANT DEVICES REPORTED: LOCKING BOLT (PART # 459.58, LOT # UNKNOWN, QTY 1). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7241194 ↗