NA 03.168.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982274427), received between Aug 20, 2019 and Jan 5, 2026 — classified as 1 injury, 21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SURGEON STRUGGLED TO GET THE FEMORAL NECK INSERTION HANDLE DETACHED FROM THE IMPLANT AS SMOOTH AS IT SHOULD BE AS THERE IS A PIECE OF METAL DENTED OVER INTO THE GROOVE. UPON INSPECTION IN SPD A BURR WAS DISCOVERED IN THE GROOVE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959540 ↗
• 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 23815848 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED IN AN UNKNOWN DATE, THE INSTRUMENT BROKE DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754886 ↗
• 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 22701646 ↗
• 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 22394846 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL NECK FRACTURE WITH THE FNS PLATE, THE INSERTION HANDLE AND THE INSERTER. AT THE END OF USING THE FNS, THE SURGEON REMOVED THE INSERTER TO REMOVE THE PLATE FROM THE INSERTION HANDLE, THE PLATE AND THE INSERTION HANDLE WERE UNABLE TO DETACH EACH OTHER. THAT PROBLEM MADE THE SITUATION UNABLE TO REMOVE THE INSERTION HANDLE BY SLIDING IT OFF THE PLATE IN A DISTAL DIRECTION. THE SURGEON USED A HAMMER, AND THEY COULD COME OFF AT THE END. AFTER THE SURGERY, THE SURGEON INFORMED THAT THERE WAS NO DEVICE ISSUE, BUT THE PLACEMENT OF THE PLATE WAS. THE INSERTION HANDLE WAS INTERFERENCE WITH THE BONE WHEN IT WAS TRIED TO SLIDE IT OFF THE PLATE IN A DISTAL DIRECTION, BECAUSE THE PROXIMAL SIDE OF THE PLATE WAS LOOSE AND HAD TILT ANGLED. THERE WAS A DEVICE INSPECTION AFTER THE SURGERY, AND THERE WAS NO ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009255 ↗
• 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 21891475 ↗
• 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 21710070 ↗
• 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 21284820 ↗
• MalfunctionJan 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING ARM FOR FEMORAL NECK SYSTEM (FNS) IS BENT CAUSING IMPLANT LOADING FAILURE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233337 ↗
• MalfunctionJun 5, 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, IT WAS NOTED THAT THE PART OF THE INSERTION INSTRUMENT WHERE THE FNS IMPLANT ATTACHES HAD SOME SCRATCHES ON IT. THE IMPLANT DID NOT SLIDE SMOOTHLY, AND IT WAS NECESSARY TO APPLY PRESSURE. THEREFORE, WHEN DISASSEMBLING THE ARM, IT WAS NECESSARY TO HIT IT WITH A HAMMER TO LOOSEN IT FROM THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059849 ↗
• 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 COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979110 ↗
• 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. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939284 ↗
• 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 13908102 ↗
• 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) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309670 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE AIMING ARM SLIPPED OUT OF THE PLATE AFTER INSERTING THE FEMORAL NECK SYSTEM (FNS). THE LOCKING COMPRESSION PLATE (LCP) SCREW WAS RELEASED AND THE AIMING ARM CAME AWAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY. CONCOMITANT DEVICE: UNK - PLATES: TRAUMA(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704166 ↗
• MalfunctionAug 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR A LEFT FEMORAL NECK FRACTURE WITH THE INSERTION HANDLE AND INSERT IN QUESTION. DURING THE SURGERY, WHEN THE SURGEON TRIED TO ASSEMBLE THE INSERTION HANDLE AND INSERT, THE BLACK THREAD PART OF THE INSERT WAS NOT CONNECTED TO THE THREAD PART OF THE INSERTION HANDLE. THE SURGEON TRIED A FEW TIMES, AND HE MANAGED TO ASSEMBLE THEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. THE THREAD PART MAY HAVE SOME PROBLEM. EXTRA BLEEDING OCCURRED BY THE SURGICAL DELAY. THIS REPORT IS FOR (1) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354153 ↗
• MalfunctionApr 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY FOR LEFT FEMORAL NECK FRACTURE. THE SURGEON ATTACHED THE 2-HOLE PLATE TO THE INSERT HANDLE AND TRIED TO TIGHTEN THE BLACK SCREW OF THE INSERT MANUALLY, BUT THE CONNECTION WAS STIFF, AND HE COULD NOT TIGHTEN THE BLACK SCREW TO THE INSERT HANDLE; IT WAS ASSUMED THAT THERE WAS A PROBLEM WITH THE PLATE. THE SURGEON EXCHANGED THE PLATE TO 1-HOLE PLATE, BUT THE SAME EVENT OCCURRED. WHEN THE PLATE WAS REMOVED FROM THE INSERT HANDLE AND THE BOLT INSERTION PORT SIDE OF THE PLATE WAS CHECKED, IT WAS FOUND THAT THE PLATE WAS SHAVED BY THE TIP OF THE INSERT. THE INSERT WAS REMOVED FROM THE INSERT HANDLE, AND THE TIP OF THE INSERT WAS TRIED TO BE ATTACHED TO THE BOLT INSERTION HOLE OF THE PLATE, BUT IT COULD NOT BE CONNECTED UNLESS IT WAS PUSHED HARD. THE SURGEON COMMENTED THAT THE TIP OF THE INSERT MIGHT BE DEFORMED OR THERE MIGHT BE A PROBLEM WITH THE PLATES. ALTHOUGH THERE WAS A GAP OF A FEW MILLIMETERS BETWEEN THE BLACK SCREW OF THE INSERT AND THE INSERT HANDLE, 2-HOLE PLATE MANAGED TO BE CONNECTED, AND THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706538 ↗
• InjuryDec 4, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE RIGHT FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM (FNS). WHILE DRILLING THE LOCKING SCREW THE SURGEON DRILLED THROUGH THE ¿2 HOLE PLATE¿ OF THE INSERTION HANDLE IN ERROR. HE DRILLED THEN THROUGH THE ¿1 HOLE PLATE¿ OF THE INSERTION HANDLE AND INSERTED A LOCKING SCREW. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. ON (B)(6) 2019, THE HOSPITAL REPORTED THAT THE PATIENT GOT A SUBTROCHANTERIC FRACTURE ON THE MISTAKENLY DRILLED POSITION (REPORTED IN (B)(4)). THE PATIENT WILL UNDERGO A REVISION SURGERY WITH ARTIFICIAL BONE AND AFN. CONCOMITANT DEVICES: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INSERT HANDLE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9411466 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY FOR FRACTURE WITH FNS. DURING THE SURGERY WHEN THE SURGEON CONNECTED THE INSERTION HANDLE, INSERT, PLATE AND BOLT, HE COULD NOT TIGHTEN THE BLACK SCREW OF THE INSERT BECAUSE IT WAS STUCK. HE TRIED CHANGING THE ANGLE AFTER UNTIGHTENING THE SCREW, BUT THE PROBLEM DID NOT IMPROVE. HE TIGHTENED THE SCREW FORCIBLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SCREW COULD BE ROTATED SMOOTHLY WHEN HE DISASSEMBLED. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. THE SALES REP CHECKED THE DEVICE AFTER THE SURGERY, BUT HE COULD NOT REPRODUCE THE PROBLEM. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 1 OF 4 FOR REPORT (B)(4).

  Patient problems: Not Applicable

  MAUDE report 9377155 ↗
• MalfunctionSep 3, 2019Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE INSERTION HANDLE, THE INSERT, THE PROTECTION SLEEVE AND THE DRILL BIT IN QUESTION. WHEN THE SURGEON TRIED TO DRILL, THE DRILL BIT INTERFERED WITH OTHER DEVICES AND IT COULD NOT REACH TO A PLATE. THE SURGEON RE-ATTACHED THE PROTECTION SLEEVE TO THE DRILL BIT AND HE COULD DRILL SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1), UNK - POWERED DRIVERS / HANDPIECES: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8958034 ↗
• MalfunctionAug 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT SURGERY INVOLVING A PLATE, A BOLT AND AN INSERT FOR INSERTION HANDLE. WHEN THE SURGEON CONNECTED THE INSERT TO THE INSERTION HANDLE, THE BLACK SCREW OF THE INSERT WAS TOO TIGHT TO TURN WITH HIS HANDS. THE SURGEON TURNED THE BLACK SCREW WITH A KOCHER FORCEPS. AFTER THE SURGERY, THE SURGEON CONFIRMED THAT THE BLACK SCREW CAN BE TURNED SMOOTHLY. THE SURGEON COMMENTED THAT THE BOLT FOR CONSTRUCT LENGTH 70MM IS NEEDED. DURING THE SURGERY, WHEN THE SURGEON DETERMINED LENGTH, HE READ 72MM. BECAUSE THE SURGEON DIDN'T HAVE THE BOLT FOR CONSTRUCT LENGTH 70MM, HE USED THE BOLT FOR CONSTRUCT LENGTH 75MM INSTEAD. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICES: FEMORAL NECK SYSTEM (FNS) PLATE (PART: 04.168.000S, LOT: 4L16980, QUANTITY: 1), FNS ANTIROTATION SCREW (PART: 04.168.475S, LOT: 04.168.475S, QUANTITY: 1), FNS LOCKING SCREW (PART: 412.217S, LOT: 2L78963, QUANTITY: 1). THIS REPORT IS FOR A FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910484 ↗