NA 357.515Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982196514), received between Feb 22, 2017 and Jan 22, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE BROWN HANDLE OF THE SCREWDRIVER WAS CHIPPED. NO OPERATION INVOLVED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144160 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE PIN FELL OUT OF THE BROWN HANDLE SCREWDRIVER, RESULTING IN THE HANDLE PORTION SPINNING WHEN TRYING TO TAKE OUT THE CONNECTING SCREW FROM THE TFNA. AS A RESULT, THE T HANDLE BALL HEX SCREWDRIVER HAD TO BE USED WHICH MANY OF THE SURGEONS DO NOT PREFER TO USE DUE TO IT HITTING THE PATIENTS HIP WHEN TURNING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211444 ↗
• 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) BALL HEX SCRDRIVER 8 FOR TI FEM NAIL. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968052 ↗
• MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, ONE OF THE STERILE PROCESSING TECHNICIANS WAS PUTTING A SET BACK TOGETHER AFTER USE AND NOTICED THE SILVER PIN ON THE BROWN HANDLE OF THE 8MM BALL HEX SCREWDRIVER WAS SITTING PROUD. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE BALL HEX SCRDRIVER 8 FOR TI FEM NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621076 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A TRAUMA PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY REMOVING THE CANNULATED CONNECTING SCREW AFTER INSERTION. UPON COMPLETION, THE CONNECTING SCREW THREADS WERE FOUND TO BE DAMAGED. THE BALL HEX SCREWDRIVER WAS DAMAGED WHILE REMOVING THE CONNECTING SCREW. THERE WAS A SURGICAL DELAY OF (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING PLIERS TO HELP REMOVE THE BOLT. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704144 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911163 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911160 ↗
• MalfunctionApr 1, 2020Device Reprocessing Problem; Device Reprocessing Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT DURING AN UNKNOWN PROCEDURE IT WAS DISCOVERED THAT BROWN SCREWDRIVER HANDLE IS STAINING. THERE WAS NO REPORTED DELAY. NO FRAGMENTS GENERATED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910533 ↗
• MalfunctionMar 12, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A TIBIAL NAIL REMOVAL OF A JIG, A BALL HEX SCREWDRIVER BROKE WHEN TRYING TO REMOVE THE ASSEMBLY JIG FROM THE TOP OF THE NAIL. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCE IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN JIG (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823520 ↗
• MalfunctionFeb 5, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE BALL HEXAGONAL SCREWDRIVER WAS ROUTED TO WASH AND IT WAS NOTICED THAT HANDLE HAD A CHIP IN IT. THE STERILE PROCESSING DEPARTMENT (SPD) CAN NO LONGER STERILIZE THE BALL HEXAGONAL SCREWDRIVER. THIS REPORT IS FOR ONE BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673126 ↗
• MalfunctionNov 15, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT FAT CAME OUT OF THE PHENOLIC HANDLE AFTER STERILIZATION WITHIN THE COMPANY RECOMMENDATION (CLEANING PH, AND STERILIZATION T). IT WAS UNKNOWN THAT IT HAPPENED DURING STERILIZATION OR FIELD INSPECTION. THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9330865 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TROCHANTERIC NAIL PROCEDURE, THE INSERTION HANDLE & CANNULATED CONNECTING SCREW WOULD NOT DISENGAGE FROM THE NAIL. ALLEGATIONS OF DEVICES INSERTION HANDLE AND CONNECTING SCREW WOULD NOT DISENGAGE FROM NAIL. BROKE WRENCH AND TWO (357.397 AND ONE 521.30) BALL HEX SCREWDRIVERS TRYING TO REMOVE INSERTION HANDLE FROM NAIL. FRAGMENTS WERE GENERATED FROM BROKEN DEVICES. SURGEON ENDED UP REMOVING THE ENTIRE CONSTRUCT AND REDID THE OPERATION WITH A DIFFERENT SET AND NEW NAIL. OTHER MEDICAL INTERVENTION WAS TO REMOVE IMPLANTED PRODUCT AND START PROCEDURE OVER WITH NEW SETS AND IMPLANTS. PROCEDURE ENDED UP BEING DONE SUCCESSFULLY WITH NEW SYSTEM AND NAIL SURGERY WAS DELAYED BY 45 MINUTES WITH NO LESS DESIRABLE OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 3 FOR 4 (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9106816 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TROCHANTERIC NAIL PROCEDURE, THE INSERTION HANDLE & CANNULATED CONNECTING SCREW WOULD NOT DISENGAGE FROM THE NAIL. ALLEGATIONS OF DEVICES INSERTION HANDLE AND CONNECTING SCREW WOULD NOT DISENGAGE FROM NAIL. BROKE WRENCH AND TWO (357.397 AND ONE 521.30) BALL HEX SCREWDRIVERS TRYING TO REMOVE INSERTION HANDLE FROM NAIL. FRAGMENTS WERE GENERATED FROM BROKEN DEVICES. SURGEON ENDED UP REMOVING THE ENTIRE CONSTRUCT AND REDID THE OPERATION WITH A DIFFERENT SET AND NEW NAIL. OTHER MEDICAL INTERVENTION WAS TO REMOVE IMPLANTED PRODUCT AND START PROCEDURE OVER WITH NEW SETS AND IMPLANTS. PROCEDURE ENDED UP BEING DONE SUCCESSFULLY WITH NEW SYSTEM AND NAIL SURGERY WAS DELAYED BY 45 MINUTES WITH NO LESS DESIRABLE OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 4 FOR 4 (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9106808 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED ON (B)(6) 2018, THE BALL HEX SCREWDRIVER SPLIT DOWN FROM THE HANDLE DURING STERILE PROCESSING. THE HANDLE HAD BEEN REPAIRED BY THE CUSTOMER¿S SHOP DEPARTMENT WITH A NON SYNTHES HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 OF FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7974738 ↗
• 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 5 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879013 ↗
• MalfunctionFeb 22, 2017Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND PROPHYLACTIC RODDING FOR A METASTATIC TUMOR IN THE FEMUR ON (B)(6) 2017. AS THE SURGEON WAS REMOVING THE INSERTION HANDLE FROM THE NAIL, THE SCREWDRIVER BROKE. THE SURGEON USED A SPARE DRIVER FROM ANOTHER TFNA SET AND WAS ABLE TO COMPLETE THE PROCEDURE WITH A FIVE (5) MINUTE TIME DELAY. NO PATIENT HARM WAS REPORTED. CONCOMITANT DEVICES REPORTED: ONE INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN), ONE NAIL (PART # UNKNOWN, LOT # UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349347 ↗