NA 04.168.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10886982274557), received between Jan 16, 2019 and Jul 10, 2025 — classified as 65 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INTERNAL FIXATION OF FEMORAL NECK FRACTURE IN THE HOSPITAL ON (B)(6) 2021. THE DEVICE WAS USED DURING THE SURGERY. RECENTLY, THE PATIENT CAME TO THE HOSPITAL FOR REMOVAL OF INTERNAL FIXATION DUE TO FEMORAL HEAD NECROSIS. AFTER REMOVAL, IT WAS NOTED THAT THE ETCHED LOT NUMBER ON THE DEVICE WAS 49P5782, BUT THE LOT NUMBER ON THE PRODUCT LABEL WAS 55P7460, THERE WERE INCONSISTENCE OF LOT INFORMATION BETWEEN DEVICE AND LABEL & SECOND SURGERY.

  Patient problems: Necrosis

  MAUDE report 22469682 ↗
• InjuryFeb 12, 2025Break; Break

  IT WAS REPORTED THAT 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. THE SURGEON PERFORMED AN OPEN REDUCTION WITH INTERNAL FIXATION ON HER HIP AND THE PATIENT UNDERWENT REHABILITATION, DILIGENTLY ATTENDING PHYSICAL THERAPY SESSIONS AT THE HOSPITAL AND LATER AT HOME. A MONTH POST-SURGERY, X-RAY REVEALED COMPLICATIONS FROM THE INITIAL SURGERY. THE SCREW HAD SNAPPED. HARDWARE REMOVED FROM LEFT HIP CONSISTING OF THREE METALLIC MEDIAL DEVICES AND METALLIC SCREW.

  Patient problems: Insufficient Information

  MAUDE report 21363212 ↗
• InjuryNov 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 20764135 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL SURGERY OF FNS IMPLANTS DUE TO OSTEONECROSIS. DURING REMOVAL OF THE 5.0MM DISTAL LOCKING SCREW WITH THE SCREWDRIVER, THE TIP OF THE SCREWDRIVER BROKE OFF AND REMAINED IN THE SCREW HEAD. THE SURGEON EXCAVATED THE SCREW HEAD AND REMOVED THE SHAFT OF THE SCREW, AND THOSE PROCEDURES TOOK APPROXIMATELY AN ADDITIONAL 40 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT IS STABLE. THE SCREWDRIVER IS A POLO PRODUCT, AND IT HAS BEEN REPORTED IN (B)(4). SINCE THE INITIAL SURGERY WITH THE FNS IMPLANTS WAS PERFORMED AT ANOTHER FACILITY, THE STANDARD OF THE 5.0MM DISTAL LOCKING SCREW IS UNKNOWN. THIS REPORT IS FOR ONE FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 19313190 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 22-NOVEMBER-2023, THE SURGEON WAS REMOVING A FNS TO DO A TOTAL HIP REPLACEMENT. THE 5MM LOCKING SCREW IN QUESTION WAS FOUND COLD WELDED TO THE PLATE, MAKING IT NECESSARY TO CUT THE PLATE TO REMOVE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18319570 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED AN FNS (FEMORAL NECK SYSTEM) IMPLANT AND INSERTED A NON-SYNTHES FEMORAL NAIL. THE PATIENT HAD BROKEN THEIR FEMUR AT THE LEVEL OF THE DISTAL END OF THE FNS PLATE. THE PATIENT VOICED THAT SHE TWISTED HER LEG AND FELT HER LEG SNAP. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 18046042 ↗
• InjurySep 22, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY WITH FNS IMPLANTS FOR A FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, CUT-OUT OCCURRED. THE FNS IMPLANTS WILL BE REMOVED, AND A REVISION THA WAS SCHEDULED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17803329 ↗
• MalfunctionMay 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF SURGERY USING A CLAVICLE PLATE L WITH THE VA LOCKING SCREW FOR CLAVICLE FRACTURE. IN THE SURGERY, THE DRIVER SHAFT¿S TIP DID NOT MATCH THE LOCKING SCREW HEAD PROPERLY. THE SURGERY WAS COMPLETED WITH A SAME SIZE NEW SCREW. THERE WAS NO SURGICAL DELAY. IT SEEMS TO BE A DEFECT IN THE RECESS OF THE LOCKING SCREW HEAD. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VA LOCKSCR A, 2.7 HE 2.4 SELF-TAP L20 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916233 ↗
• MalfunctionMay 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF SURGERY USING A CLAVICLE PLATE L WITH THE VA LOCKING SCREW FOR CLAVICLE FRACTURE. IN THE SURGERY, THE DRIVER SHAFT¿S TIP DID NOT MATCH THE LOCKING SCREW HEAD PROPERLY. THE SURGERY WAS COMPLETED WITH A SAME SIZE NEW SCREW. THERE WAS NO SURGICAL DELAY. IT SEEMS TO BE A DEFECT IN THE RECESS OF THE LOCKING SCREW HEAD. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914191 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A REMOVAL OF FEMORAL NECK SYSTEM, 1 HOLE PLATE, BROKEN 5.0 TI LOCKING SCREW. ALL IMPLANTS WERE REMOVED, REVISED WITH A TOTAL HIP. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16840403 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE FNS PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, FEMORAL HEAD OSTEONECROSIS WAS CONFIRMED. ON FEBRUARY 17, 2023, THE FNS PLATE WILL BE REMOVED, AND A THA WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PL 1 HOLE - STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis

  MAUDE report 16492405 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD SUBTROCHANTERIC FRACTURE BELOW A 1 HOLE FNS (FEMORAL NECK SYSTEM) PLATE WITH 1 LOCKING SCREW. LATER THE PLATE WAS REMOVED AND REVISED WITH A CEPHALOMEDULLARY NAIL. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16390395 ↗
• MalfunctionNov 28, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON COMPLETED A FNS AND WAS NOT PLEASED ON HOW THE PLATE WAS SITTING ON THE FEMUR. THE PLATE WAS SITTING POSTERIOR AND SLIGHTLY OFF OF THE BONE. THE SURGEON ACCEPTED THE RESULTS AND COMPLETED THE SURGERY. IT IS POSSIBLE THAT THE REASONING IS BECAUSE THE SURGEON FREE HANDED THE GUIDE WIRE. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870219 ↗
• InjurySep 27, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE REVISION OF FEMORAL NECK SYSTEM DUE TO CUT THROUGH. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. SOME FRAGMENTS WAS GENERATED. PATIENT STATUS/ OUTCOME: UNKNOWN THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PL 1 HOLE - STERILE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Unspecified Tissue Injury

  MAUDE report 15493708 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL NECK FRACTURE WITH FNS IMPLANTS. AFTER SURGERY ON (B)(6) 2022, THE PATIENT COMPLAINED OF PAIN, AND SUBTROCHANTERIC FRACTURE OF FEMUR AT THE AREA WHERE THE LOCKING SCREW OF FNS WAS INSERTED WAS CONFIRMED. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, FNS IMPLANTS WERE REMOVED AND REPLACED WITH FEMORAL RECON NAIL IMPLANTS TO FIX THE FRACTURE SITE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15364575 ↗
• MalfunctionAug 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A REVISION PROCEDURE PERFORMED ON (B)(6) 2022, THE FNS PLATE WAS DIFFICULT TO REMOVE. THE SURGEON USED A REMOVAL DEVICE AND A T-SHAPED SCREWDRIVER, BUT WAS UNABLE TO REMOVE THE FNS PLATE. EVENTUALLY, CARBIDE WAS USED TO COMPLETE THE REMOVAL OF THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312027 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FEMORAL NECK FRACTURE WITH THE FNS IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER 10 WEEKS OF THE SURGERY, SIGNIFICANT IMPLANT SLIDING WAS OBSERVED IN THE PATIENT WHO HAD DISCHARGED ALREADY. IN (B)(6) THE PATIENT WAS HOSPITALIZED AND FOLLOWED UP, BUT BONE NONUNION WAS OBSERVED ON (B)(6) 2022. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. FNS IMPLANTS WILL BE REMOVED AND REPLACED WITH BHA. THE SURGEON COMMENTED THAT THE PATIENT HAS A HISTORY OF OSTEOPOROSIS AND THE PRESENT NONUNION WAS DUE TO THE PATIENT'S BONE QUALITY AND NOT DUE TO THE IMPLANT. THE PATIENT DOES NOT HAVE IMPLANTS CUT-OUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PL 1-HO F/FEM NECK SYST TAN. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15302823 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT INITIAL SURGERY WITH FNA IMPLANTS FOR FRACTURE OF FEMORAL NECK. AFTER SURGERY, AROUND ON (B)(6) 2022, THE PATIENT VISITED THE HOSPITAL AND COMPLAINED OF PAIN. ON (B)(6) 2022, IT WAS CONFIRMED VIA X-RAY THAT THE PLATE TELESCOPED, AND THE BONE HEAD WAS INVAGINATED CAUSING NON-UNION. ON (B)(6) 2022, REVISION SURGERY WAS PERFORMED VIA BHA. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 15013430 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE THREE INTERLOCKING PARTS OF THE FEMORAL NECK SYSTEM BROKE APART FROM EACH OTHER WHEN THEY WERE IMPLANTED. THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787082 ↗
• InjuryJun 15, 2022Adverse 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 THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE FNS IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE BONE UNION FAILURE WAS CONFIRMED ON AN UNKNOWN DATE. A REVISION SURGERY PERFORMED ON (B)(6) 2022. THE FNS IMPLANTS WERE REMOVED AND REPLACED WITH THA. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES (1) FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 14702587 ↗
• InjuryMay 31, 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 CUSTOMER THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN FEMORAL NECK SYSTEM DEVICES REMOVED TO DO A TOTAL HIP PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

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

  MAUDE report 14546472 ↗
• MalfunctionMay 25, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PROCEDURE WAS AN IMPLANTATION OF AN FNS. DRILLING THE LOCKING HOLE FOR INSERTING THE 5.0 LOCKING SCREW, THE DRILL GOT STUCK IN THE PROTECTION SLEEVE, FOR THE FEMORAL NECK SYSTEM INSERTION INSTRUMENTS. THE DOCTOR COULD NOT MOVE THE DRILL IN ANY WAY. THE FNS WAS TAKEN OUT OF THE PATIENT AND AN DHS WAS INSERTED. THIS REPORT INVOLVES ONE (1) THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498191 ↗
• InjuryMay 23, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A FNS REMOVAL AS IT APPEARED TO BE FRACTURED NEAR DISTAL INTERLOCK. IT WAS REPORTED THAT THERE WAS NO IMPLANT BREAKAGE. ACCORDING TO THE REPORT, DURING REMOVAL, DISTAL LOCKING SCREW WAS COLD WELDED TO PLATE AND SURGEON USED MIDAS REX TO CUT IT OUT. THE PATIENT OUTCOME AND OTHER MEDICAL INTERVENTION WAS UNKNOWN. THE COMPLAINT INVOLVES ONE (1) DEVICE.

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

  MAUDE report 14469628 ↗
• InjuryMay 4, 2022Adverse 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 THAT ON (B)(6) 2022, PATIENT UNDERWENT THE SURGERY FOR THE NON-DISPLACED FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM (FNS) IMPLANTS. ON DAY OF THE SURGERY, THE IMAGE CONFIRMED THAT THE BONE FRACTURE PART HAD BECOME DISPLACED. THE BONE FRACTURE HAD CHANGED FROM A NON-DISPLACED FRACTURE TO A DISPLACED FRACTURE. HOWEVER, AS THE OSTEOSYNTHESIS IMPLANT WAS PREPARED, THE SURGERY WAS CONTINUED WITHOUT CHANGE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. CURRENT PATIENT HAS NOT BEEN ABLE TO APPLY WEIGHT-BEARING DUE TO FRACTURE METASTASIS. THE SURGEON JUDGED THAT BONE UNION IS NOT EXPECTED AND SCHEDULED REVISION SURGERY ON (B)(6) 2022. THE FNS IMPLANTS WILL BE REMOVED AND REPLACED WITH AN ARTIFICIAL HEAD IMPLANT. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS REPORT IS FOR FNS PLATE.

  Patient problems: Malunion of Bone

  MAUDE report 14282000 ↗
• 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 1 OF 4 FOR (B)(4). THIS REPORT IS FOR A FEMORAL NECK SYSTEM PLATE.

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

  MAUDE report 14025264 ↗