NA 03.168.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982274434), received between Nov 16, 2018 and Sep 1, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550606 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE INS F/INSERTION HANDLE EXPERIENCED A FAILURE DURING A PROCEDURE. THE EVENT INVOLVED THE SILVER PIECE ATTACHED TO THE BLACK SCREW OF THE INSERTION ASSEMBLY COMING OFF WHEN THE SCREW WAS TIGHTENED FOR THE 95MM FNS BOLT. THE SILVER PIECE WAS FOUND TO HAVE NO THREADS, PREVENTING IT FROM BEING SCREWED BACK ON, WHICH REQUIRED OPENING ANOTHER FNS TRAY TO COMPLETE THE PROCEDURE. THIS RESULTED IN A FIVE-MINUTE DELAY, BUT THERE WERE NO REPORTED PATIENT CONSEQUENCES OR IMPACT TO THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269155 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL FEMORAL FRACTURES. WHEN ATTACHING THE IMPLANT, THE BLACK SCREW ON THE FNS INSERTER WAS STIFF AND DIFFICULT TO TURN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON WAS ABLE TO REMOVE THE DEVICE AFTER THE SURGERY WITHOUT ANY PROBLEMS; IT WAS NOTED THAT THE SCREW WAS NOT STIFF WITHOUT THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815888 ↗
• MalfunctionDec 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, INSERTION HANDLE INSERT NOT COUPLING PROPERLY. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781771 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED IN AN UNKNOWN DATE; THE INSTRUMENT BROKE DURING SPD. THE EVENT OCCURRED DURING STERILE PROCESSING, FIELD INSPECTION AND DURING CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754882 ↗
• MalfunctionAug 4, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED DURING A PROCEDURE THE FEMORAL NECK SYSTEM (FSN) MISSED THE TARGETER COMPLETELY; THE DRILL WAS SET TO 95MM BUT OVERDRILLED TO 100MM. THERE WAS NO IMPACT ON THE PATIENT. IT WAS NOTED THERE WAS RUST ON THE FSN ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701665 ↗
• MalfunctionJul 29, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS RUST ON FEMORAL NECK SYSTEM (FNS) ITEMS, AND NEED REPLACING DUE TO FNS DRILL BIT HITTING. THE X2 CANNULATED SCREWS BROKE WHILE INSERTING IN FEMORAL NECK. THE SCREW (03.354.460) BROKE IN FEMORAL NECK. IT SNAPPED IN HALF WHILE INSERTING. THE FNS MISSED THE TARGETER COMPLETELY AND WHENEVER WE SET THE DRILL TO 95MM IT OVER DRILLED TO 100MM. IT KEPT SLIDING FOR SOME REASON. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651282 ↗
• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER USE OF OVERTIME, THE INSERTION HANDLE PIECES HAVE BECOME HARD TO ATTACH ON THE IMPLANT. IT WAS NOTICED THAT THERE WAS SOME DAMAGE ON THE INSTRUMENTS AND TESTED IT ON THE DEMO IMPLANTS. THE INSERTION HANDLE HAD TO BE FORCED ONTO THE IMPLANTS AND HAS BECOME HARD TO REMOVE AS WELL. IT WAS NOT AN INTRAOPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394847 ↗
• MalfunctionApr 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTION HANDLE CAME LOOSE FROM FNS IMPLANT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891493 ↗
• MalfunctionMar 27, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE INSERTION HANDLE APPEARED TO BE CROSS-THREADED INTO FNS INSERTION HANDLE ALLOWING CERTAIN AMOUNT OF SPACE. THE INSERTION HANDLE CONNECTING TO THE FNS PLATE AND BOLT WAS NOT SECURED DUE TO CROSS THREAD. IMPLANT STILL SUCCESSFULLY IMPLANTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710115 ↗
• MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE FNS AIMING ARM WAS NOT SCREWING TOGETHER, IT APPEARED THAT THE BLACK KNOB WAS STICKING TO THE THREADS. THERE WAS 5 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. A DIFFERENT FNS TRAY WAS UTILIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284860 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION HANDLE AND IMPACTOR BROKE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613701 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE INSERT FOR FEMORAL NECK FRACTURE. DURING SURGERY, COMPRESSION COULD NOT BE APPLIED BY TURNING THE BLACK SCREW OF THE INSERT COUNTERCLOCKWISE. THE BLACK SCREW AND THE CYLINDRICAL PART HOLDING IT LOOSENED AND CAME FROM THE INSERT, AND COMPRESSION COULD NOT BE APPLIED. THE INSERT WAS REMOVED FROM THE FIXED IMPLANT BY A PLIER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH THE BONE FIXATION. PATIENT WAS LISTED AS STABLE AFTER SURGERY, THE SALES REP AND THE SURGEON INSPECTED THE INSERT. THE INSERT, WHICH WAS ORIGINALLY AN INTEGRATED UNIT, WAS DIVIDED INTO THREE PARTS. ALL THE PARTS WERE ABLE TO PULL OUT AND COMPLETELY REMOVED. THIS REPORT IS FOR INSERT FOR FNS INSERTION HANDLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192894 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BACK MOST PIECE OF THE FNS (FEMORAL NECK SCREW) INSERTION HANDLE INSERT CAME OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19906378 ↗
• MalfunctionJun 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE AT THE HOSPITAL WITH DR. SHIN, THEY COULD NOT GET THE MULTIFUNCTION ROD TO THREAD INTO THE AIMING ARM/ANTIROTATION SCREW. ALSO, BECAUSE OF THIS, THEY WERE NOT ABLE TO GET MUCH COMPRESSION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY, FRAGMENTS GENERATED OR THE PATIENT'S OUTCOME. NO FURTHER INFORMATION TO REPORT AT THIS TIME. THIS REPORT IS FOR ONE (1) INSERT FOR FNS INSERTION HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19594387 ↗
• MalfunctionNov 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE INSERTION HANDLE IN QUESTION WAS FOUND TO CATCH WHEN INSERTED INTO OTHER INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE WHEN ATTACHING A PLATE, BUT WAS REPLICATED POST-OP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18114096 ↗
• MalfunctionOct 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ANTIROTATION SCREW FAILED TO ADVANCE THROUGH THE TUBE IN THE JIG. THEY DOUBLE CHECKED THERE WERE NOT OBSTRUCTIONS AND THAT THE DRILL HAD BEEN USED TO THE APPROPRIATE DEPTH FOR THE IMPLANT. HOWEVER SOMETHING STILL WAS OBSTRUCTING THE ADVANCEMENT OF THE IMPLANT. THE DOCTOR REQUESTED WE REPLACE THE PART ASAP.THIS REPORT IS FOR ONE (1) INS F/INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17913509 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR A RIGHT FEMORAL NECK FRACTURE. THE FNS PLATE IN QUESTION FELL ON THE UNCLEAN FIELD WHEN THE SURGEON CONNECTED THE FNS PLATE TO THE HANDLE AND WAS ABOUT TO BE TIGHTENED BY THE INSERTER. THE INSERTER'S DIAL C COULD NOT BE TURNED SMOOTHLY, AND THE SURGEON'S ATTENTION WAS FOCUSED ON THE DIAL C, WHICH CAUSED THE ENTIRE HANDLE TO ROTATE. FURTHERMORE, SINCE THE FIELD WHERE THE OPERATION OF DIAL C WAS PERFORMED CHANGED FROM THE CLEAN FIELD TO THE UNCLEAN FIELD DURING THIS OPERATION, THE IMPLANT, WHICH WAS POORLY CONNECTED, FELL ON THE UNCLEAN FIELD WHEN IT WAS DISCONNECTED FROM THE HANDLE. SINCE THERE WAS NO REPLACEMENT FOR THE PLATE AND THE STERILIZER COULD NOT BE OPERATED DUE TO THE CONTRACTOR'S VACATION, THE PROCEDURE WAS PERFORMED VIA A HANSSON PINLOC SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 35 MINUTES DELAY. SURGICAL TIME WAS EXTENDED DUE TO THE DETERMINATION AND CONFIRMATION OF THE AVAILABILITY OF HANSSON PINLOC SYSTEM AND THE PROCEDURAL TIME FOR IMPLANT FIXATION. THE PLANNED SURGICAL TIME WAS 45 MINUTES. AFTER SURGERY, THE SURGEON CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979030 ↗
• MalfunctionApr 27, 2023Break; Mechanical Problem; Break; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR TREATING THE FEMORAL NECK. THE SURGEON PROCEEDED ACCORDING TO THE SURGICAL TECHNIQUE, AND AT THE END OF PROCEDURES, THE SURGEON TRIED TO APPLY COMPRESSION. WHILE APPLYING COMPRESSION BY TIGHTENING A BLACK SCREW OF THE INSERTER, A SILVER PART UNDER THE BLACK SCREW CAME OFF, AND THE SURGEON COULD NOT APPLY COMPRESSION SUFFICIENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823187 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A FEMORAL NECK SYSTEM PART HAD TWO PIECES THAT CAME APART. THE SURGERY OUTCOME WAS GOOD, AND THERE WAS NO DELAY IN THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682143 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE FEMORAL NECK FRACTURE OSTEOSYNTHESIS FOR FEMORAL NECK FRACTURE WITH THE PRODUCTS IN QUESTION. DURING THE SURGERY, THE SURGEON FOLLOWED THE GUIDEWIRE INSERTION, MEASUREMENT, AND DRILLING PROCEDURES, SLIDING AND ATTACHING THE PLATE TO THE INSERTION HANDLE WITH THE 2HOLE PLATE AND 95 MM NECK BOLT SET. HE INSERTED THE INSERTER FROM BEHIND AND WHEN HE DID THE SCREW INSTALLATION, A NURSE SAID IT WAS TOO HARD AND THE SCREW WOULD NOT TURN. THEY TRIED SEVERAL TIMES TO REINSERT THEM, BUT THEY NEVER SEEMED TO GO IN, SO THEY DISMANTLED EVERYTHING AND CHECKED THE IMPLANTS VISUALLY. NECK BOLT AND PLATE CONFORMITY WAS NOT A PROBLEM. THERE WAS SIGNIFICANT RESISTANCE WHEN INSERTING THE PLATE AND INSERTER. THEY PUSHED HARDER AND MANAGED TO GET THEM IN, SO THEY AGAIN ATTEMPTED TO ATTACH THE IMPLANTS USING A COMBINATION OF HANDLE AND INSERTER. IT WAS OBVIOUS TO THE NAKED EYE THAT THE INSERTER WAS MORE ADVANCED THAN AT FIRST, SO THEY USED THE T-CHUCK HANDLE OF THE JACOBS CHUCK TO FORCEFULLY TURN THE C SCREW. ALTHOUGH FORCEFUL, THE INSTALLATION WAS COMPLETED, AND SINCE THERE WERE NO APPAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444202 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR FEMORAL NECK FRACTURE WITH THE PRODUCT IN QUESTION. PREOPERATIVE INSPECTION SHOWED NO PROBLEMS. DURING THE SURGERY, THE SURGEON CHECKED FOR PLATE FLOAT AFTER INSERTING THE NECK BOLT AND ANTI-ROTATION SCREW. HE ATTACHED THE 03-168-010 MULTIFUNCTION ROD IN A COMPRESSION TECHNIQUE, TURNED THE BLACK RING ON THE INSERTER, AND ATTEMPTED TO CRIMP THE PLATE. HOWEVER, THE SILVER PART AT THE HAND OF THE BLACK RING KEPT COMING OFF, CAUSING NO COMPRESSION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO INFECTIOUS DISEASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) INS F/INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971311 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY WITH THE PRODUCTS IN QUESTION. AFTER THE SURGEON INSERTED THE GUIDEWIRE AND FINISHED REAMING IMPLANT INSERTION, HE NOTICED THAT THE BLACK SCREW ON THE INSERTER WAS LOOSE WHILE INSERTING THE DISTAL SCREW. HE TRIED TO RE-TIGHTEN IT, BUT IT HAD A STRANGE BITE AND COULD NOT BE TIGHTENED ANY FURTHER. HE REMOVED THE SCREW, DISCONNECTED THE INSERTION HANDLE CONNECTING THE IMPLANT, AND WAS INSTRUCTED TO COMPLETELY REMOVE THE BLACK SCREW AND GENTLY TURN IT IN. IT WAS STUCK FOR A WHILE, BUT AFTER SEVERAL ATTEMPTS, HE WAS FINALLY ABLE TO TURN IT IN CORRECTLY. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH THE REINSERTION OF THE IMPLANT AND THE SCREWS. THERE WAS A DELAY OF 30 MINUTES. THIS REPORT INVOLVES ONE INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939282 ↗
• MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IMPLANTATION OF AN FNS. DRILLING THE LOCKING HOLE FOR INSERTING THE 5.0 LOCKING SCREW. THE DRILL GOT STUCK IN THE PROTECTION SLEEVE, FOR FEMORAL NECK SYSTEM INSERTION INSTRUMENTS. THE DR COULD NOT MOVE THE DRILL IN ANY WAY. THE FNS WAS TAKEN OUT OF THE PATIENT AND AN DHS WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908079 ↗
• MalfunctionJan 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE FEMORAL NECK FRACTURE WITH THE FNS. THE NURSE TRIED TO TIGHTEN THE BLACK SCREW OF THE INSERT FOR ATTACHING THE IMPLANT ONTO THE INSERTION HANDLE, BUT IT WAS STIFF TO TIGHTEN. THE BLACK SCREW OF THE INSERT WAS TIGHTENED WITH FORCEPS CAREFULLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) INSERT FOR FNS INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309675 ↗