NA 412.214SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982275417), received between Jul 24, 2019 and Aug 13, 2025 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL NECK FRACTURE WITH LOCKING SCREW. ALTHOUGH A SINGLE-HOLE FNS PLATE WAS USED, AND SURGEON INSERTED THE LOCKING SCREW AFTER A LATERAL LOCKING DRILLING TO THE DISTAL TWO-HOLE SIDE. THIS WAS FOUND OUT AFTER THE LOCKING SCREW WAS INSERTED, BUT THE SURGEON WAS CONCERNED THAT REMOVING THE LOCKING SCREW COULD RESULT IN A FRACTURE, SO HE LEFT THE LOCKING SCREW IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22797668 ↗
• InjuryFeb 5, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD A GROUND-LEVEL FALL AND SUFFERED A BROKEN HIP, AFTER A BUSY DAY AT WORK TEACHING YOGA. DESPITE HER PAIN, PATIENT INITIALLY ATTRIBUTED IT TO FATIGUE. BUT, AS THE DISCOMFORT WORSENED, SHE KNEW SOMETHING WAS WRONG. BY 10AM, SHE FOUND HERSELF IN THE EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH A BROKEN FEMUR. ON (B)(6) 2023 THE SURGEON PERFORMED AN OPEN REDUCTION WITH INTERNAL FIXATION ON HER HIP AND UNDERWENT REHABILITATION, DILIGENTLY ATTENDING PHYSICAL THERAPY SESSIONS AT THE HOSPITAL AND LATER AT HOME. A MONTH POST-SURGERY, ON (B)(6) 2023, X-RAY REVEALED COMPLICATIONS FROM THE INITIAL SURGERY. THE SCREW HAD SNAPPED EITHER DUE TO ERROR OR PRODUCT MALFUNCTIONING. ON (B)(6) 2023 HARDWARE REMOVED FROM LEFT HIP CONSISTING OF THREE METALLIC MEDIAL DEVICES AND METALLIC SCREW.

  Patient problems: Insufficient Information

  MAUDE report 21312473 ↗
• InjuryNov 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DOCTOR PROCEEDED TO REMOVE ALL OF THE IMPLANTS FROM THE PATIENT LEFT PROXIMAL FEMUR. ONCE THERE IS ACCESS TO THE IMPLANTS, DOCTOR COULD NOT DISENGAGE THE TITANIUM 5.0MM LOCKING SCREW (40MM) FROM THE (FNS) 1 HOLE TITANIUM PLATE. AFTER SEVERAL ATTEMPTS USING MULTIPLE T25 SCREW DRIVERS, THE SCREW APPEARED TO BE STRIPPED. HE THEN PROCEEDED TO USE EASY OUT INSTRUMENTS FROM ANOTHER VENDOR. AFTER MULTIPLE ATTEMPTS, HE THEN PROCEEDED TO USE 4MM DIAMOND BURRS TO ATTEMPT TO REMOVE THE SCREW HEAD. HE PROCEEDED TO REMOVE THE ANTI ROTATION SCREW FROM THE BOLT USING A T25 SCREWDRIVER. HE SUCCEEDED IN REMOVING BOTH THE ANTIROTATION SCREW (100MM) AND THE BOLT WITH MINIMUM RESISTANCE. AFTER REMOVING THE TWO IMPLANTS (BOLT AND ANTI ROTATION SCREW), HE CONTINUED TO ATTEMPT TO REMOVE THE 1 HOLE PLATE AND 5.0MM LOCKING SCREW. HE THEN ATTEMPTED TO USING A LARGE/WIDE ELEVATOR AND SLID IT UNDERNEATH THE PLATE, AND THEN USED A MALLET HIT THE BACK OF THE HANDLE OF THE ELEVATOR TO LIFT THE PLATE AND SCREW OFF OF THE BONE (PROXIMAL FEMUR). HE WAS ABLE TO LIFT IT OFF ENOUGH TO ATTACH HEAVY DUTY VICE GRIPS AND ATTACH A SLAP HAMMER AND REMOVE ALL OF THE IMPLANTS. NO FURTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20761782 ↗
• InjuryAug 8, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FNS (FEMORAL NECK SCREW) CUTOUT. DURING A REMOVAL PROCEDURE, THE FNS LOCKING SCREW WAS COLD WELDED INTO THE PLATE. THE PATIENT HAD AN ADDITIONAL FRACTURE DURING REMOVAL OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT TOOK LONGER THAN EXPECTED ACCORDING TO THE SURGEON. THE PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17479970 ↗
• InjuryAug 8, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FNS (FEMORAL NECK SCREW) CUTOUT. DURING A REMOVAL PROCEDURE, THE FNS LOCKING SCREW WAS COLD WELDED INTO THE PLATE. THE PATIENT HAD AN ADDITIONAL FRACTURE DURING REMOVAL OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT TOOK LONGER THAN EXPECTED ACCORDING TO THE SURGEON. THE PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17479969 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REVISION PROCEDURE TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2022 AS THE FEMORAL NECK SYSTEM DEVICES COLLAPSED. ACCORDING TO THE REPORT, THE IMPLANTS WERE INSIDE THE PATIENT FOR ROUGHLY ONE MONTH. THE STATUS OF THE PATIENT POST-REVISION PROCEDURE WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE DEVICE. THIS COMPLAINT INVOLVES 4 DEVICES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14169942 ↗
• InjuryApr 6, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE FNS FOR A MEDIAL FRACTURE OF THE FEMORAL NECK. THE PATIENT FELL SEVERAL WEEKS AFTER THE SURGERY AND WAS UNDER OBSERVATION. MIGRATION/CUT-OUT WAS CONFIRMED ON (B)(6) 2022. THE REVISION SURGERY FOR REMOVAL OF THE FNS AND THE BIPOLAR HIP ARTHROPLASTY WILL BE PERFORMED ON (B)(6) 2022. ALTHOUGH THE FRACTURE WAS OUTSIDE THE SCOPE OF THE OSTEOSYNTHESIS, THE SURGEON DECIDED TO PERFORM THE OPEN REDUCTION INTERNAL FIXATION WITH THE FEMORAL NECK SYSTEM (FNS) TO REDUCE BLEEDING BECAUSE OF THE UNDERLYING DISEASE. THIS EVENT MIGHT HAVE BEEN CAUSED BY THE FALL. REVISION SURGERY WAS DONE ON (B)(6) 2022. FNS IMPLANTS IN QUESTION WERE REMOVED AND REPLACED WITH BHA. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH 1 HOUR DELAY. THE DELAY IN SURGERY IS DUE TO INSTRUMENT BREAKAGE OF OTHER COMPANIES' PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW FOR FNS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14025522 ↗
• MalfunctionOct 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING A REMOVAL OF AN FNS TO CONVERT TO A TOTAL HIP, THEY ENCOUNTERED A LOCKED SCREW. WHEN TRYING TO REMOVE THE 5.0 LOCKING SCREW FROM THE 1 HOLE PLATE, THE SCREW COULD NOT BE REMOVED. THE SURGEON ALSO ATTEMPTED REMOVING THE ANTIROTATION SCREW, A PORTION OF THE FEMORAL HEAD, AND THE FNS BOLT. SEVERAL ATTEMPTS WERE MADE TO LOOSEN THE SCREW WITH VARIOUS AMOUNTS OF TORQUE, BOTH WITH AND WITHOUT POWER. THE SURGEON FINALLY USED A CARBINE DRILL BIT TO BUR OFF THE HEAD OF THE SCREW AND CORE AROUND THE SHAFT TO REMOVE IT COMPLETELY. THERE WAS A 30 TO 45 MINUTE SURGICAL DELAY NOTED. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT CONSEQUENCES NOTED. THIS REPORT IS FOR 1 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682549 ↗
• InjuryJun 28, 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 PATIENT BROKE HER FEMUR BELOW THE HARDWARE THAT WAS IN. THE FEMORAL NECK SYSTEM (FNS) IMPLANTS WERE REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 40-SILE THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081200 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION PROCEDURE OF THE FEMORAL NECK SYSTEM (FNS) DEVICES DUE TO A BREAK BELOW THE FNS PLATE SECONDARY TO FALL. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE ORIGINAL DEVICES ON (B)(6) 2020. IT WAS MENTIONED THAT THERE WAS NO HARDWARE THAT WAS BROKEN, JUST THE BONE AROUND IT. DURING THE REVISION PROCEDURE, THE FNS IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A TROCHANTERIC FIXATION NAIL ADVANCED(TFNA) DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11142436 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON HAD TO REMOVE THE FEMORAL NECK PLATE DUE TO PAIN, THE LOCKING SCREW WAS LOCKED INTO THE PLATE AND IT WOULD NOT COME OUT SO THE SURGEON USED AN UNKNOWN METAL CUTTING BURR TO CUT INTO THE PLATE. THE SURGEON WAS THEN ABLE TO BACK OUT THE LOCKING SCREW AND WAS ALSO ABLE TO REMOVE THE ANTI-ROTATION SCREW, THE BOLT AND THE PLATE. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10951300 ↗
• InjuryDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON HAD TO REMOVE THE FEMORAL NECK PLATE DUE TO PAIN, THE LOCKING SCREW WAS LOCKED INTO THE PLATE AND IT WOULDN'T COME OUT SO THE SURGEON USED AN UNKNOWN METAL CUTTING BURR AND CUT INTO THE PLATE AND THEN THE SURGEON WAS ABLE TO BACK OUT THE LOCKING SCREW AND WAS ALSO ABLE TO REMOVE THE ANTI-ROTATION SCREW, THE BOLT AND THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS REPORT IS 2 OF 2 FOR (B) (4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10945517 ↗
• InjurySep 8, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS CONVERTING THE PATIENT TO TOTAL HIP ARTHROPLASTY. THE 5.0 MM LOCKING SCREW WAS STRIPPED BUT WAS REMOVED SUCCESSFULLY. ACTION TAKEN WHEN THE EVENT OCCURRED INCLUDED SCREW REMOVAL SET AND A MIDAS REX TO REMOVE THE STRIPPED SCREW. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE INTRA-OP EVENT OF THE STRIPPED 5.0 MM LOCKING SCREW. (B)(4) CAPTURES THE POST-OP EVENT OF THE PATIENT EXPERIENCING PAIN.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10501191 ↗
• InjurySep 4, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS CONVERTING THE PATIENT TO TOTAL HIP ARTHROPLASTY. THE PATIENT WAS EXPERIENCING PAIN AND NEEDED TO REMOVE A FEMORAL NECK SYSTEM PLATE AND SCREWS. NOTHING WAS BROKEN. THE 5.0 MM LOCKING SCREW WAS STRIPPED BUT WAS REMOVED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR 1 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10497008 ↗
• InjuryJun 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. THE SURGEON WAS REMOVING THE FEMORAL NECK SYSTEM 1-HOLE PLATE BECAUSE THE SURGEON WAS CONVERTING THE FEMORAL NECK SYSTEM 1-HOLE PLATE TO A HEMIARTHROPLASTY. THE FEMORAL HEAD HAD COLLAPSED, AND THE BOLT AND THE ANTI-ROTATIONAL SCREW WERE NO LONGER ENGAGED IN THE FEMORAL HEAD. WHILE ATTEMPTING TO REMOVE THE TITANIUM LOCKING SCREW THROUGH THE FEMORAL NECK SYSTEM 1-HOLE PLATE, IT WAS DISCOVERED THAT THE TITANIUM LOCKING SCREW WAS COLD-WELDED INTO THE FEMORAL NECK SYSTEM 1-HOLE PLATE. THE SCREW HEAD BECAME STRIPPED DUE TO MULTIPLE ATTEMPTS TO REMOVE IT WITH THE SCREWDRIVER. THE SURGEON HAD TO USE A BURR TO WEAKEN THE SCREW AND USE BOLT CUTTERS TO CUT THE SCREW FROM THE PLATE. THE SURGEON WAS ABLE TO FINALLY REMOVE EVERYTHING WITH EXTRA EFFORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY-MINUTE (30) OF SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN FNS ANTI-ROTATION (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1); UNKNOWN FNS BOLT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT I

  Patient problems: No Code Available

  MAUDE report 10105916 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SUBTROCHANTERIC FRACTURE SUBSEQUENT TO THEIR INITIAL FRACTURE. THE PATIENT¿S ORIGINAL INJURY HAD NOT HEALED, AND A SECOND FRACTURE OCCURRED IN THE FEMUR, JUST DISTAL TO THE SIDE PLATE. THE SURGEON REMOVED ALL IMPLANTS; FEMORAL NECK SYSTEM PLATE, ANTIROTATION SCREW, FEMORAL NECK BOLT, 40MM TITANIUM LOCKING SCREW AND 30MM TITANIUM LOCKING SCREW. PATIENT WAS REVISED WITH A NON-SYNTHES GAMMA NAIL. ORIGINALLY, THE PATIENT WAS TREATED FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW 40MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

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

  MAUDE report 8823474 ↗