NA 412.215SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982275424), received between Jun 18, 2019 and Nov 19, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERNAL THREADS WERE STRIPPED DUE TO THREAD IN MECHANISM BEING OFF AXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593075 ↗
• MalfunctionNov 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERNAL THREADS WERE STRIPPED DUE TO THREAD IN MECHANISM BEING OFF AXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569018 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH LOCKING SCREW. WHEN THE SURGEON ATTEMPTED TO INSERT INTO THE LATERAL LOCKING OF FNS PLATE, HE INSERTED THE LOCKING SCREW IN QUESTION WHILE PRESSING DOWN ON THE DEVICE TO PREVENT THE PLATE FROM FLOATING. HOWEVER, EXCESSIVE PRESSURE CAUSED THE DEVICE TO SHIFT, AND THE LOCKING SCREW IN QUESTION WAS INSERTED IN A DIRECTION DIFFERENT FROM THE DRILLED HOLE. THE LOCKING SCREW IN QUESTION BECAME LOCKED DURING INSERTION, SO THE SURGEON USED A HAMMER TO FIRMLY BITE THE TIP OF THE DRIVER BEFORE REMOVING IT. HOWEVER, THE NEXT TIME THE DRIVER SHAFT AND SCREW HEAD BECAME TIGHTLY STUCK, SO THE SURGEON USED PLIERS AND A HAMMER TO REMOVE THE LOCKING SCREW IN QUESTION FROM THE DRIVER SHAFT. THE PART THAT HAD BEEN BITTEN BY THE PLIERS BECAME DEFORMED, SO A NEW SCREW WAS USED TO FIX IT, AND THE SURGERY WAS COMPLETED. ALTHOUGH THE LENGTH OF THE NEW SCREW WAS 2 MM LONGER THAN THE LOCKING SCREW IN QUESTION, THE SURGEON DETERMINED THAT IT WAS THE APPROPRIATE LENGTH EVEN UNDER INTRAOPERATIVE FLUOROSCOPY, SO THE WOUND WAS CLOSED AS IS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827549 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM. ON (B)(6) 2023, THE PATIENT SUSTAINED A STANDING HEIGHT FALL; X RAY IMAGES TAKEN REVELED A FRACTURE DISTAL TO THE FEMORAL NECK SYSTEM (FNS) PLATE. THE PATIENT WAS BROUGHT TO THE OR ON (B)(6) 2023, FOR REMOVAL OF THE FNS AND REVISION TO LONG TFNA NAIL. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17475307 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM. ON (B)(6) 2023, THE PATIENT SUSTAINED A STANDING HEIGHT FALL; X RAY IMAGES TAKEN REVELED A FRACTURE DISTAL TO THE FEMORAL NECK SYSTEM (FNS) PLATE. THE PATIENT WAS BROUGHT TO THE OR ON (B)(6) 2023 FOR REMOVAL OF THE FNS AND REVISION TO LONG TFNA NAIL. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17475306 ↗
• MalfunctionApr 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY WITH THE FEMORAL NECK SYSTEM (FNS) IMPLANTS. AFTER THE SURGERY, REVISION SURGERY WAS COMPLETED ON (B)(6) 2022, DUE TO THE BONE UNION FAILURE, FEMORAL NECK SHORTENING AND PAIN. IN THIS REVISION SURGERY, THE SURGEON HAD DIFFICULTY REMOVING THE FNS IMPLANTS. A HANDLE/LARGE WITH QUICK COUPLING AND AT25 STARDRIVE¿ SCREWDRIVER SHAFT WAS USED TO REMOVE THE FNS IMPLANTS, BUT THE IMPLANTS COULD NOT BE REMOVED DUE TO THE DISTAL SCREW BEING FIXED FIRMLY. ANOTHER COMPANY¿S SCREWDRIVER WAS USED FOR THE REMOVAL, AND THE SCREWDRIVER TIP BECAME STRIPPED. IT WAS SUGGESTED TO USE THE INSERTION HANDLE WITH FORCE AND ATTEMPT REMOVAL, BUT THE SURGEON CHOSE TO USE A CARBIDE DRILL. THE PLATE CAME OFF, BUT THE TIP OF SCREW REMAINED IN THE BONE. ANOTHER COMPANY'S INSTRUMENT WAS USED, AND RESIDUAL FRAGMENTS COULD BE REMOVED. THE REMOVAL OF IMPLANT FOR DELAYED UNION OF FEMORAL NECK FRACTURE AND ARTIFICIAL HEAD REPLACEMENT WERE COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS (B)(4) IS LINKED TO (B)(4) WHICH REPORTS ABOUT THE BONE U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027875 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO COLLAPSED FEMORAL NECK. THE PATIENT FELL WHICH CAUSED THE FEMORAL NECK TO COLLAPSE. THE IMPLANTS DID NOT FAIL OR BROKE, BUT THEY COLLAPSED SIGNIFICANTLY ALONG WITH THE FEMORAL NECK REQUIRING A CONVERSION. THE SURGEON REMOVED A FEMORAL NECK SYSTEM (FNS) AND CONVERTED TO A TOTAL HIP ARTHROPLASTY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 11586004 ↗
• InjuryFeb 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, A DISTAL BROKEN SCREW WAS BROKEN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT FELT PAIN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11259997 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ADDITIONAL FRACTURES OCCURRED POST-OPERATIVELY AND WERE CONFIRMED BY X-RAY FOR A FEMORAL NECK SYSTEM (FNS). REVISION SURGERY OCCURRED ON (B)(6) 2020, IN WHICH THE FNS IMPLANTS WERE REMOVED AND THE PATIENT REVISED TO A BIPOLAR HIP ARTHROPLASTY (BHA). THE ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FEMORAL NECK FRACTURES USING THE FNS SYSTEM OCCURRED (B)(6) 2020. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10250587 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE SURGEON REPORTED A PATIENT WITH A NEW FRACTURE NEAR A PLATE FROM THE FEMORAL NECK SYSTEM (FNS) CONSTRUCT. THE INITIAL SURGERY WAS CONDUCTED ON (B)(6) 2020 AND WAS SUCCESSFULLY COMPLETED. THE FNS CONSTRUCT APPEARS TO BE INTACT WITHOUT WRAPPING OR ANY IMPLANT FRAGMENTATION. ORIGINALLY THE IMPLANTED DEVICES WERE: TWO (2) TITANIUM LOCKING SCREW, ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) BOLT, AND ONE (1) ANTI-ROTATION SCREWS. IT WAS UNKNOWN IF THERE WAS A REVISION OR HARDWARE REMOVAL. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9971654 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE SURGEON REPORTED A PATIENT WITH A NEW FRACTURE NEAR A PLATE FROM THE FEMORAL NECK SYSTEM (FNS) CONSTRUCT. THE INITIAL SURGERY WAS CONDUCTED ON (B)(6) 2020 AND WAS SUCCESSFULLY COMPLETED. THE FNS CONSTRUCT APPEARS TO BE INTACT WITHOUT WRAPPING OR ANY IMPLANT FRAGMENTATION. ORIGINALLY THE IMPLANTED DEVICES WERE: TWO (2) TITANIUM LOCKING SCREW, ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) BOLT, AND ONE (1) ANTI ROTATION SCREWS. IT WAS UNKNOWN IF THERE WAS A REVISION OR HARDWARE REMOVAL. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9971563 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2020, DUE TO NON-UNION AND BREAKAGE OF TWO (2) LOCKING SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES: BOLT FOR FEMORAL NECK SYSTEM (PART: 04.168.295S, LOT: 3L42036, QUANTITY: 1) ANTIROTATION SCREW (PART: 04.168.500S-US, LOT: L874140, QUANTITY: 1), FEMORAL NECK SYSTEM PLATE (PART: 04.268.000S, LOT: 3L42036, QUANTITY: 1), 5.0MM LOCKING SCREW 42MM (PART: 412.215S, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW 42MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9792608 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONCOMITANT DEVICES REPORTED: UNKNOWN FNS BOLT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND UNKNOWN FNS ANTIROTATION SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8708779 ↗