NA 03.010.517Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886982069306), received between Mar 10, 2017 and Jun 6, 2025 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, USER WAS UNABLE TO STERILIZE/ASSEMBLE. ITEMS WERE CHIPPING AND CRACKING. USER WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157678 ↗
• InjuryMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANTS WERE DAMAGED AND WHEN SURGEON TRIED TO REMOVE THE INSTRUMENT, IT WAS IMPOSSIBLE TO RELEASE THE NAIL FROM THE INSTRUMENT, SO HE HAD TO REMOVE ALL THE IMPLANTS AND LEAVE THE PATIENT WITH THE INITIAL INJURY. SURGEON PLANNED TO REOPERATE PATIENT ON (B)(6) 2025. ADDITIONALLY, WHEN REVIEWING THE NEW PARTS INVOLVED IN THE SURGERY PERFORMED, IT WAS NOTICED THAT THE INSERTION ARCH WAS FUSED TO THE TFNA NAIL BY MEANS OF THE CONNECTION SCREW FOR THE INSERTION ARCH AND HAS INTERNAL SCRATCHES, ALONG WITH THE IMPLANTS THAT WERE REMOVED DUE TO THIS NEW PART. IT WAS IMPOSSIBLE TO DISASSEMBLE THE INSERTION ARCH AND THE NAIL TO SUCH AN EXTENT THAT THE T-HEAD SCREWDRIVER THAT SECURES THE CONNECTING SCREW BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21949103 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE CONNECTING SCREW WAS HARD TO DISENGAGE FROM THE INSERTION HANDLE INTRA-OPERATIVELY. THE T-HANDLE BALL HEX SCREWDRIVER WAS SKIPPING INSIDE THE CONNECTING SCREW. IT WAS VERY HARD TO DISENGAGE. THE SCREWDRIVER MIGHT BE WORN. THE CONNECTING SCREW WAS CHANGED. THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117789 ↗
• MalfunctionNov 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ON ONE KIT TFNA IT WAS NOTICED THE FOLLOWING ISSUES : THE RED AND YELLOW MARKINGS ON THE GUIDE SLEEVE AS WELL AS THOSE OF THE IMPACTOR ARE ERASED. THE TWO CONNECTION SCREWS DO NOT FIT WITH THE HEXAGON SCREWDRIVER 8MM. THESE REFERENCES ARE SUPPOSED TO ALLOW GRIPPING. THE PROTECT SLEEVE DOES NOT FIT PROPERLY INTO THE CARBON AIM ARMS AND SLIPPING, WHICH IS ANNOYING DURING THE INTERVENTION. CARBON AIM ARMS ARE INCOMPLETE : THE "RING" VISIBLE IS MISSING. THE LISTING OF THIS INSTRUMENT IS, IN FACT, UNCLEAR. THESE REFERENCES SHOULD INCLUDE THREE ELEMENTS (CARBON VISOR, SCREW AND RING), EACH WITH ITS OWN REFERENCE. ISSUE NOTICED BY THE SALES REP DURING A TRAINING WITH THE USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779507 ↗
• MalfunctionSep 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR THE FEMORAL TROCHANTERIC FRACTURE. AT THE END OF THE OPERATION, WHEN THE SCREWDRIVER WAS ATTACHED TO THE CONNECTING SCREW TO REMOVE THE CONNECTION BETWEEN THE INSERTION HANDLE AND THE NAIL, THE SCREW COULD NOT BE REMOVED. THE SURGEON TURNED THE SCREWDRIVER REPEATEDLY BY FORCE, AND THE SCREW WAS ABLE TO BE REMOVED. THE SURGERY ENDED WITHOUT ISSUE. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258934 ↗
• MalfunctionApr 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 20, 2024, DURING A TFNA PROCEDURE THE DEVICE BROKE. THE DOCTOR HAD TO CHANGE THE TFNA IMPLANT BECAUSE THE INSERTION HANDLE COULD NOT BE REMOVED. A NEW SENT WAS OBTAINED AND THE IMPLANT WAS CHANGED. THERE WAS A FORTY-FIVE (45) MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19053470 ↗
• MalfunctionMar 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON 26-FEBRUARY-2024 WHILE REMOVING THE CONNECTING SCREW ON THE TFNA, THE 8MM T-HANDLE HEX SPUN INSIDE OF THE CONNECTING SCREW. UPON CLOSER INSPECTION, THE 8MM T-HANDLE LOOKS LIKE THE 8MM HEX WAS STRIPPING OUT AS WELL AS THE CONNECTING SCREW. EVERYTHING CAME OUT SMOOTHLY ONE THEY WERE ABLE TO GET THE SCREW TO BREAK LOOSE A LITTLE BIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897459 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE CONNECTING SCREW WAS STRIPPING AT THE TIME OF REMOVAL. THEY FINALLY REMOVED WITH A DIFFERENT T HANDLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. AFTER THE CASE THEY WERE ABLE TO IDENTIFY THE OTHER SETS ALSO HAD DAMAGED OR ¿EXTREME WEAR¿ ON THE T25 DRIVERS , CONNECTING SCREWS AND T HANDLES. THE SURGEON REQUESTED TO REPLACE THESE ITEMS AS THEY WERE KEY COMPONENTS TO SUCCESSFULLY REMOVING THE INSERTION HANDLE AFTER SURGERY. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18769341 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE CONNECTING SCREW WAS STRIPPING AT THE TIME OF REMOVAL. THEY FINALLY REMOVED WITH A DIFFERENT T HANDLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. AFTER THE CASE THEY WERE ABLE TO IDENTIFY THE OTHER SETS ALSO HAD DAMAGED OR ¿EXTREME WEAR¿ ON THE T25 DRIVERS , CONNECTING SCREWS AND T HANDLES. THE SURGEON REQUESTED TO REPLACE THESE ITEMS AS THEY WERE KEY COMPONENTS TO SUCCESSFULLY REMOVING THE INSERTION HANDLE AFTER SURGERY. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18769311 ↗
• MalfunctionFeb 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE CONNECTING SCREW WAS STRIPPING AT THE TIME OF REMOVAL. THEY FINALLY REMOVED WITH A DIFFERENT T HANDLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. AFTER THE CASE THEY WERE ABLE TO IDENTIFY THE OTHER SETS ALSO HAD DAMAGED OR ¿EXTREME WEAR¿ ON THE T25 DRIVERS , CONNECTING SCREWS AND T HANDLES. THE SURGEON REQUESTED TO REPLACE THESE ITEMS AS THEY WERE KEY COMPONENTS TO SUCCESSFULLY REMOVING THE INSERTION HANDLE AFTER SURGERY. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18768586 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 4 OF 4 FOR (B)(4) .

  Patient problems: Insufficient Information

  MAUDE report 18703038 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703036 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE CONNECTING SCREW WAS STRIPPING DURING REMOVAL. THE SCREW WAS ULTIMATELY REMOVED USING A DIFFERENT T-HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. AFTER THE PROCEDURE, OTHER SETS OF DRIVERS, CONNECTING SCREWS AND T-HANDLES WERE IDENTIFIED WITH DAMAGE OR EXTREME WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703031 ↗
• MalfunctionAug 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE FINISHING UP A HIP FRACTURE THE T-HANDLE BALL HEX SCREWDRIVER BECAME BENT. WHILE TRYING TO REMOVE THE CONNECTING SCREW FROM THE NAIL WITH THIS INSTRUMENT IT BECAME BENT. THE PATIENT WAS OBESE WHICH MADE IT DIFFICULT TO GET THIS SCREWDRIVER INTO THE JIG TO REMOVE THE INTERLOCKING BOLT FROM THE NAIL DUE TO THE STRESS OF GETTING THROUGH THE SOFT TISSUE. IN ORDER TO AVOID ADDED STRESSES ON THIS INSTRUMENT IT WAS DECIDED TO OPEN A DIFFERENT SET AND USE A DIFFERENT T HANDLE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT, THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH USE OF A DRIVER FROM A DIFFERENT SET. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540146 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE. LAST NIGHT, WE WERE DOING A TFNA SURGERY AND THE TFNA WOULD NOT DISENGAGE FROM THE CONNECTING SCREW ONCE THE PROCEDURE WAS FINISHED. THE SURGEON ACTUALLY BROKE THE 8MM BALL HEX WHEN TRYING TO DISENGAGE THE NAIL FROM THE RADIOLUCENT JIG. WE HAD A BACKUP. THERE WAS A DELAY IN SURGERY ,THAT LASTED ABOUT 20 MINUTES. WE HAD BACKUPS, SO THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT IS DOING FINE THE BLUE T HANDLE (03.010.517) BROKE OFF AT THE TIP WHILE TRYING TO TAKE THE JIG (03.037.012) OFF OF THE NAIL. THE BOLT (03.037.010), THAT HOLDS THE NAIL TO THE JIG WAS CROSS THREADED IN SUCH A WAY THAT WE COULD NOT GET THE NAIL OFF OF THE JIG. AFTER THE CASE WAS OVER, MULTIPLE ATTEMPTS WERE TRIED TO TAKE THE NAIL OFF OF THE JIG, AND WE WERE NEVER ABLE TO GET IT SEPARATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES SCRDRIVER-HEX Ø8 W/T-HANDLE W/SPHERIC-HE. THIS IS REPORT 4 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826081 ↗
• MalfunctionDec 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A TFNA NAIL FAILED TO DISENGAGE FROM THE JIG. IT SEEMED AS THOUGH THE DEVICE HAS BEEN CROSS-THREADED THE NAIL WAS IMMEDIATELY EXPLANTED AND REPLACED BY ANOTHER TFNA NAIL. IN THE PROCESS OF TRYING TO DISENGAGE THE NAIL FROM THE JIG THE HEXALOBE SCREWDRIVER BROKE AND THE BALL WAS RETAINED IN THE SOCKET. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946303 ↗
• MalfunctionNov 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CONNECTION SCREW AND NAIL GOT STUCK TOGETHER. THE THREAD OF THE CONNECTION SCREW AND NAIL WERE BROKEN. A T-HANDLE BECAME TWISTED BECAUSE THE SURGEON HAD TO USE EXTRA FORCE TO UNSCREW THEM. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814034 ↗
• MalfunctionNov 8, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEMS NEED REPLACING DUE TO WEAR AND TEAR. THERE WAS NO SURGICAL DELAY. A SECOND SET WAS OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT AFFECTED. THIS REPORT INVOLVES ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752924 ↗
• MalfunctionOct 5, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, AN ISSUE OCCURRED DURING A TIBIAL NAILING PROCEDURE WHEREIN THE DRILL BIT HIT STATIC ONE AFTER COMPRESSION MODE WAS USED. WHILE FINISHING THE PROCEDURE AND TAKING OFF THE INSERTION HANDLE, THE T-HANDLE CANNULATED DRIVER WAS STRIPPED. A SOLID T-HANDLE WAS OPENED AND IT DID NOT GET IT OFF EITHER. A SECOND T-HANDLE WAS OPENED AND THE SURGEON WAS FINALLY ABLE TO GET THE INSERTION HANDLE OFF AFTER RAISING THE LEG. THERE WAS A FIVE-MINUTE SURGICAL DELAY AS A RESULT OF THIS EVENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544364 ↗
• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED ON JULY 1, 2022, THAT THE HEXAGONAL SCREW DRIVER WAS FOUND BROKEN. THE PART IS SPD. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168062 ↗
• MalfunctionAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS SEEM TO HAVE BEEN AFFECTED BY THE HIGH TEMPERATURES OF THE WASHING/STERILIZATION PROCESS. SOME OF THE PLASTICS MELTED AND THE RUBBERS ON SOME TOOLS ARE OILY AND STICKY. THERE IS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138054 ↗
• MalfunctionMar 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022 A NAIL IMPLANTATION PROCESS WAS CARRIED OUT ACCORDING TO THE TECHNIQUE GUIDE, HOWEVER, AT THE END WHEN PROCEEDING TO REMOVE THE ARCH FROM THE NAIL, THE CONNECTION BOLT DID NOT COME OUT WITH THE SCREWDRIVER. AFTER SEVERAL ATTEMPTS, THE PART OF THE BOLT FRACTURED AND ITS HEAD ROLLED, SO IT WAS DECIDED TO REMOVE THE TFNA SCREW FIRST AND THEN THE NAIL. WHEN REMOVING THE NAIL, IT WAS OBSERVED THAT THE NAIL WAS CORRECTLY ADAPTED TO THE ARCHWIRE, IT HAD NOT ENTERED CROOKEDLY. AN ATTEMPT WAS MADE TO REMOVE THE NAIL AGAIN AND IT WAS NOT POSSIBLE. SO IT WAS DECIDED TO PASS THE CASE TO OTHER TFNA TEAM AND IMPLANT ANOTHER NAIL. THERE WAS A SURGICAL DELAY OF NINETY (90) MINUTES. PATIENT OUTCOME IS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637804 ↗
• MalfunctionFeb 23, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE SCREWDRIVER TIP BROKE OFF DURING RELEASE OF THE CONNECTING SCREW TO REMOVE THE INSERTION HANDLE. THE SPHERICAL HEXAGONAL TIP OF THE SCREWDRIVER REMAINED IN THE CONNECTING SCREW AND COULD NOT BE REMOVED. THE SURGEON DECIDED TO CUT OFF THE INSERTION HANDLE WITH A CYLINDRICAL BURR TO RELEASE THE INSERTION HANDLE FROM THE NAIL. FRAGMENTS WERE GENERATED FROM THE DISTAL THREADED PART OF THE CONNECTING SCREW. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586838 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, WHEN THE CASE WAS FINISHED IT WAS DISCOVERED THAT THE T-HANDLE BALL/HEX SCREWDRIVER HAD A SMALL BEND IN THE SHAFT. THE CASE WAS ALREADY COMPLETED, AND THERE WAS NO PATIENT IMPACT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE HEX BALL TIP WAS STRIPPED. THIS REPORT IS FOR A T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236631 ↗
• MalfunctionDec 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, IT WAS DIFFICULT TO REMOVE THE CONNECTING SCREW FROM THE TFNA. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) T-HANDLE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 3 OF 9 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980087 ↗