NA 03.010.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10886982067173), received between Dec 30, 2013 and Jun 17, 2025 — classified as 7 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE TWO PIECES OF THE LFN INSTRUMENTAL BROKE DURING THE SURGICAL PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233656 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AN INSERTION HANDLE WAS BROKEN AND NEED TO HAVE THE PIECE REPLACED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072216 ↗
• MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826474 ↗
• MalfunctionNov 15, 2023Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE DEVICE IN QUESTION WAS OPENED UP AND FOUND TO HAVE RUSTED. THE INSERTION HANDLE IN QUESTION HAD A RUSTED NOTCH, MAKING IT DIFFICULT TO MOUNT TO THE NAIL. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18140152 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CONNECTOR FOR INSERTION HANDLE WASN¿T ABLE TO BE REMOVED FROM THE INSERTION HANDLE. NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/EXPERT TN+FN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650479 ↗
• MalfunctionJul 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE PROTECTION SLEEVE DID NOT PASS THROUGH THE ANTEROGRADE LOCKING HOLE IN THE INSERTION ARC. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404389 ↗
• MalfunctionJun 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE LFN NAIL WAS MOUNTED TO THE INSERTION ARC AND DELIVERED TO THE SURGEON. WHEN THE SURGEON BEGAN TO INTRODUCE THE NAIL INTO THE FEMORAL CANAL WITH A HAMMER, IT WAS NOTICED THAT THE NAIL OF THE INSERTION ARC HAD LOOSENED. THE SURGEON WAS UNABLE TO TIGHTEN THE NAIL WITH A BALL SCREWDRIVER AND PASS THE BROC. IT WAS FOUND THAT THE NAIL WAS RELEASED FROM THE INSERTION ARCH BECAUSE THE CONNECTION NOTCH HAD BROKEN. BECAUSE OF THIS, THE DRILL BIT SPLIT WHEN IT COLLIDED WITH THE NAIL. DISTAL INTERLOCKS WERE MADE USING ANOTHER DRILL BUT, BUT THE DRILL BIT BENT IN THE BORE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239019 ↗
• MalfunctionJun 12, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  THE HANDLE WAS CROSS-THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17104678 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, THE CUSTOMER REPORTED THAT THE TROCAR CANNOT BE PUSHED THROUGH THE ANGLED TARGET IN THE INSERTION HANDLE. THIS REPORT INVOLVES ONE (1) INSERT-HANDLE F/EXPERT TN+FN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16977703 ↗
• MalfunctionMay 12, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DR. HANNA WAS PERFORMING A SHAFT FEMUR FRACTURE FIXATION ON A YOUNG PATIENT USING AN EXPERT RAFN IM NAIL. DURING THE INITIAL PROCEDURE, HE FELT SIGNIFICANT RESISTANCE WHILE REAMING THE INITIAL ENTRY POINT (PIRIFORMIS FOSSA). AFTER SUCCESSFULLY OPENING THE ENTRY POINT, HE STARTED REAMING WITH A SYNTHES FLEXIBLE REAMER AND FELT THE SAME RESISTANCE ON EACH REAMER ADVANCEMENT. WITH EXCESSIVE FORCE, THE FLEXIBLE SHAFT BROKE INTO THREE PARTS WHEN HE WAS REMOVING THE REAMER FROM THE CANAL. SINCE THE FLEXIBLE REAMER SET COMES WITH TWO SHAFTS, THE SURGEON CONTINUED REAMING UP TO THE DESIRED DIAMETER (15.5 MM). HE THEN DECIDED TO USE A 14X440 RAFN NAIL. WHILE TRYING TO INTRODUCE THE NAIL INTO THE IM CANAL, HE ALSO ENCOUNTERED GREAT RESISTANCE. USING A HAMMER, HE ADVANCED THE NAIL TO THE UPPER 1/3 OF THE FEMUR BUT THEN IT WOULD NOT ADVANCE FURTHER. HE DECIDED TO REMOVE THE NAIL AND USE A SMALLER DIAMETER NAIL, THE RAFN 13X440 NAIL. HOWEVER, IT WAS EXCEEDINGLY DIFFICULT TO REMOVE THE NAIL FROM THE CANAL, AND THE NAIL BECAME STUCK IN THE CANAL, CAUSING A DELAY OF APPROXIMATELY 20 MINUTES. WHILE ATTEMPTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919372 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION HANDLE AND PROTECTION SLEEVE STAYED LOCKED TOGETHER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763524 ↗
• MalfunctionMar 22, 2023Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, INTRA-OPERATIVELY THE INSERTION HANDLE & CONNECTOR SCREW CROSS THREADED. THE SURGEON TRIED TO UNDO THE CONNECTING SCREW USING THE COMBINATION WRENCH AND PIN WRENCH; THE ITEMS GOT STUCK AND BROKE. NO PATIENT INVOLVEMENT. THE EVENT OCCURRED INTRA-OP AND POST-OP, UNDOING THE INSERTION HANDLE AND CONNECTOR SCREW. THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592676 ↗
• InjuryDec 16, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2022, THE SURGEON HAD AN ANTEGRADE RAFN FULLY INSERTED INTO THE FEMUR. HE BEGAN TO ROTATE THE NAIL WITH THE INSERTION HANDLE. AN AUDIBLE POP WAS HEARD AND IT WAS EVIDENT THAT SOMETHING WAS AMISS WHEN THE PROXIMAL TARGETED INTERLOCKS MISSED THROUGH THE AIMING ARM. UPON COMPLETION OF THE PROCEDURE, IT WAS NOTICED THAT THE TOOTH THAT CONNECTS THE NAIL TO THE INSERTION HANDLE HAD BROKEN OFF, MAKING THE INSERTION HANDLE ROTATE FREELY AROUND THE NAIL. THE TOOTH REMAINED IN THE PROXIMAL PORTION OF THE NAIL. THE PATIENT HAD A LEFT FEMORAL SHAFT FRACTURE. THERE WAS A SURGICAL DELAY OF 8 MINUTES. PERFECT CIRCLES WERE COMPLETED PROXIMALLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO CLINICAL OUTCOME EXPERIENCED BY THE PATIENT. NO OTHER MEDICAL INTERVENTION WAS NECESSARY. THIS REPORT INVOLVES ONE STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15996964 ↗
• MalfunctionNov 29, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882262 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 3901330000-2022-8068 , A FRAGMENT BROKE OFF FROM THE NOSE/TIP OF THE INSTRUMENT IN QUESTION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759405 ↗
• InjuryJul 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY ON AN UNKNOWN DATE IN 2022 WITH LATERAL FEMORAL NAIL (LFN), SURGEON HAD IMMENSE DIFFICULTY IN PLACING PROXIMAL SCREWS. IT HAD AN IMPACT ON THE PATIENT AND EVERYONE IN THE ROOM AS THEY WERE MORE EXPOSED TO THE X-RAY BECAUSE MORE INTENSIVE USE OF THIS METHOD FOR VIEWING WAS REQUIRED. THERE WAS UNSPECIFIED AMOUNT OF SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS ALSO ALTERED, WHICH MADE THE SURGERY MORE INVASIVE. THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15112757 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TWO PIECES COULD NOT BE SEPARATED AFTER USE. ANOTHER SET OF INSTRUMENTS WAS USED FOR THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065831 ↗
• MalfunctionJul 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TWO PIECES COULD NOT BE SEPARATED AFTER USE. ANOTHER SET OF INSTRUMENTS WAS USED FOR THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065773 ↗
• MalfunctionJun 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY THE NAIL WAS NOT IN THE RIGHT PLACE AND THE POSITION NEEDED TO BE CORRECTED. WHILE ATTEMPTING TO ADJUST THE POSITION OF THE WHOLE CONSTRUCT, THE INSTRUMENTS JAMMED AND THE TIP OF THE AIMING ARM BROKE OFF. THIS REPORT IS FOR AN INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712541 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A TIBIAL NAILING SURGERY ON (B)(6), 2022, THE CONNECTOR AND INSERTION HANDLE WERE JAMMED NOT ABLE TO BE DISASSEMBLED. IN THE PROCEDURE, THE CONNECTOR AND INSERTION HANDLE WERE ASSEMBLED BEFORE THE NAIL WAS INTRODUCED INTO THE MEDULLARY CANAL. DURING INSERTION, THE SURGEON HAMMERED THE CONNECTOR TO GET THE NAIL PROPERLY INSERTED. THE ASSEMBLING WAS DONE ACCORDING TO RECOMMENDED OPERATION TECHNIQUE AND IFU. FURTHER DISASSEMBLY EFFORT WAS MADE BOTH AFTER WASHING AND STERILISATION AT THE HOSPITAL AND ALSO AFTER RETURN AT THE DISTRIBUTOR¿S OFFICE WITH NO SUCCESS. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193021 ↗
• MalfunctionApr 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT ATTEMPTED TO TAKE APART A STANDARD INSERTION HANDLE FROM A DRIVING CAP WITH HANDLE ADAPTER BUT THEY ARE ACTING LIKE THEY ARE COLD WELDED AND WILL NOT DISASSEMBLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR THE INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187615 ↗
• MalfunctionApr 13, 2022Break; Break

  THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/EXPERT TN+FN. IT WAS REPORTED THAT A SYNTHES STANDARD INSERTION HANDLE BROKE AFTER A PROCEDURE. THE TIP OF THE HANDLE WAS STATED TO HAVE BROKEN OFF IN THE WASHER. THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104251 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, LFN IN LARGE PATIENT. RETROVERTED FEMORAL HEAD. REQUIRED A LOT OF MOVEMENT FOR THE VERSION ON THE HIP SCREWS TO LINE UP. WHILE TRYING TO ADJUST VERSION A LOT OF FORCE WAS PLACED ON THE JIG, CAUSING THE TOOTH OF THE AIMING ARM TO SNAP AND THE NAIL TO BE BECOME MISALIGNED. THE NAIL HAD TO BE REMOVED. THE JIG WAS INSPECTED AND THEN REPLACED BY ANOTHER AIMING JIG FROM RAFN SET. PROCEDURE THEN CONTINUED. SURGEON ADMITS TO EXCESSIVE FORCE PLACED ON JIG CAUSING IT TO BREAK. THERE WAS A FEW MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/EXPERT TN+FN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054098 ↗
• MalfunctionMar 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  PLEASE REVIEW THIS ELEMENT BECAUSE THE PROTECT HIST 12/8 L 188 SHEATH DOES NOT ENTER SMOOTHLY AND GETS STUCK AT ITS TIP, IN THE 120º ANTEGRADE GUIDE HOLE, AS SHOWN IN THE ATTACHED PHOTO. THIS COMPLAINT INVOLVES ONE (1) DEVICE INSERT-HANDLE F/EXPERT TN+FN. THIS REPORT IS FOR ONE (1) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660286 ↗
• MalfunctionFeb 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENT INSERT-HANDLE F/EXPERT TN FN DIDN´T WORK AS IT WAS SUPPOSED TO. THE TINY ¿TOOTH¿ ON THE HANDLE IS BROKEN AND HAD TO CHANGE TO ANOTHER NAILING SYSTEM. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/EXPERT TN FN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498519 ↗