NA 357.417Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982196408), received between Mar 28, 2018 and May 3, 2021 — classified as 19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FLEXIBLE HEXAGONAL SCREWDRIVER COATED WAS UNABLE TO BE CLEANED SATISFACTORILY. THE ISSUE WAS DISCOVERED IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 5.0 FLEXIBLE HEXAGONAL SCRDRIVER COATED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759850 ↗
• MalfunctionOct 9, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN SURGERY, WHEN THE SURGEON WENT TO BLOCK THE NAIL, HE MADE A LOT OF FORCE AND THE SCREWDRIVER RANG AND BROKE. TWO (2) GUIDE WIRES WERE ALSO BENT DURING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656859 ↗
• MalfunctionMay 21, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE STAFF DISCOVERED THE BLACK SHAFT OF THE 5.0MM FLEXIBLE SCREWDRIVER FROM THE TFN LOCKING SET IS KINKED AND NO LONGER WORKS PROPERLY TO TIGHTEN THE SHIM IN PLACE NOR REMOVE THE HELICAL BLADE COUPLING SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN INSERTION INSTRUMENTS: CONNECTING/COUPLING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080656 ↗
• MalfunctionMar 5, 2019Break; Break

  IT WAS REPORTED THAT THE FLEXIBLE HEXAGONAL SCREWDRIVER COATED BROKE DURING A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) PROCEDURE ON (B)(6) 2019. IT BROKE WHEN THE SURGEON WAS TIGHTENING DOWN THE INTERNAL LOCKING MECHANISM OF TFNA. THERE WAS NO PROBLEM IN THE CASE, A SECOND NEWER FLEXIBLE HEXAGONAL SCREWDRIVER COATED IN AND SURGERY PROCEEDED WITH NO PROBLEM. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390802 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, ONE (1) FLEXIBLE HEXAGONAL SCREWDRIVER COATED BROKE. IT IS UNKNOWN WHEN WAS THE ISSUE DISCOVERED. IT IS UNKNOWN IF THERE WAS A PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071756 ↗
• MalfunctionSep 17, 2018Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7883588 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879019 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879014 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE DURING AN UNKNOWN SURGERY, A FLEXIBLE HEXAGONAL SCREWDRIVER BROKE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7842578 ↗
• MalfunctionMar 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES CONSULTANT THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE THE SURGERY ON (B)(6) 2018, THEY DISCOVERED A SMALL THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN BALL HEX SCREWDRIVER 8MM, SEVEN HEXAGONAL SCREWDRIVER, FIVE STARDRIVE SCREWDRIVER T25/SELF-RETAINING AND THREE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. ALL THESE SCREWDRIVERS WERE THE PARTS OF TWO TFN LOCKING TRAYS, TWO TFN INSERTION TRAYS, TWO EXPERT TIBIAL NAIL SETS AND TWO EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. ALL THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT ADDRESSES EIGHT (8) DEVICES; REMAINING FOURTEEN (14) DEVICES ARE CAPTURED IN COMPLAINT FILES (B)(4). THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7382707 ↗
• MalfunctionMar 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES CONSULTANT THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE THE SURGERY ON (B)(6) 2018, THEY DISCOVERED A SMALL THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN BALL HEX SCREWDRIVER 8MM, SEVEN HEXAGONAL SCREWDRIVER, FIVE STARDRIVE SCREWDRIVER T25/SELF-RETAINING AND THREE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. ALL THESE SCREWDRIVERS WERE THE PARTS OF TWO TFN LOCKING TRAYS, TWO TFN INSERTION TRAYS, TWO EXPERT TIBIAL NAIL SETS AND TWO EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. ALL THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT ADDRESSES EIGHT (8) DEVICES; REMAINING FOURTEEN (14) DEVICES ARE CAPTURED IN COMPLAINT FILES (B)(4) AND (B)(4). THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7382692 ↗
• MalfunctionMar 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES CONSULTANT THAT WHEN THE MEDICAL DEVICE REPROCESSING (MDR) STAFF WAS CHECKING THE DEVICES BEFORE THE SURGERY ON (B)(6) 2018, THEY DISCOVERED A SMALL THIN AMOUNT OF TRANSLUCENT GREASE UNDERNEATH THE HANDLES OF SEVEN BALL HEX SCREWDRIVER 8MM, SEVEN HEXAGONAL SCREWDRIVER, FIVE STARDRIVE SCREWDRIVER T25/SELF-RETAINING AND THREE 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED. ALL THESE SCREWDRIVERS WERE THE PARTS OF TWO TFN LOCKING TRAYS, TWO TFN INSERTION TRAYS, TWO EXPERT TIBIAL NAIL SETS AND TWO EXPERT RETROGRADE/ANTEROGRADE FEMORAL NAIL SETS. ALL THESE ITEMS WERE QUARANTINED AND NONE OF THEM WERE USED IN THE SURGERY. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS REPORT ADDRESSES EIGHT (8) DEVICES; REMAINING FOURTEEN (14) DEVICES ARE CAPTURED IN COMPLAINT FILES (B)(4). THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7382668 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382462 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382461 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 4 OF 10 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382458 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382456 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382449 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  (B)(6) REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR USING A TROCHANTERIC FIXATION NAIL (TFN) INSTRUMENTATION, THE STAFF NOTICED WHAT APPEARED TO BE GREASY RESIDUE ON THE UNDERSIDE OF THE HANDLE OF A FLEXIBLE HEXAGONAL SCREWDRIVER COATED. IT WAS PUT ASIDE AND ANOTHER TRAY WAS OPENED, BUT THE INSTRUMENT OF THE SAME PART NUMBER WAS OPENED WITH THE SAME ISSUE. A THIRD TRAY WAS OPENED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS OR PATIENT HARM. THERE WAS NO SURGICAL TIME DELAY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378806 ↗
• MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  (B)(6) REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR USING A TROCHANTERIC FIXATION NAIL (TFN) INSTRUMENTATION, THE STAFF NOTICED WHAT APPEARED TO BE GREASY RESIDUE ON THE UNDERSIDE OF THE HANDLE OF A FLEXIBLE HEXAGONAL SCREWDRIVER COATED. IT WAS PUT ASIDE AND ANOTHER TRAY WAS OPENED, BUT THE INSTRUMENT OF THE SAME PART NUMBER WAS OPENED WITH THE SAME ISSUE. A THIRD TRAY WAS OPENED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS OR PATIENT HARM. THERE WAS NO SURGICAL TIME DELAY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378795 ↗