NA 04.005.526SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982085955), received between May 2, 2018 and Jul 3, 2025 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE IS A SUBSTANCE IN THE STERILE PACKAGE. IT LOOKS LIKE A HARD PLASTIC OBJECT. THIS WAS NOTED INTRAOPERATIVELY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393844 ↗
• MalfunctionMar 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON MARCH 5, 2024, THAT THE SURGICAL TEAM WAS PERFORMING A HIP FRACTURE FIXATION WITH OUR TFNA SYSTEM. WHEN THE CIRCULATING NURSE OPENED 04.005.526S TO IMPLANT, SHE NOTICED A HAIR ON THE INNER STERILE PACKAGING. ANOTHER SCREW WAS OPENED, AND THE CASE WAS COMPLETED. THE SURGERY WAS DELAYED FOR 2 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950181 ↗
• InjuryFeb 14, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE TFNA FOR THE FEMORAL TROCHANTERIC FRACTURE. AT THE TIME OF INJURY, IT WAS P TYPE, SO THAT THE ELEVATOR WAS USED TO CHANGE TO TYPE A. THEN, IT WAS FIXED. AT ONE WEEK POSTOPERATIVELY, THE PATIENT WAS PROGRESSING WELL WITH THE EXPECTED AMOUNT OF SLIDING. APPROXIMATELY THREE MONTHS AFTER SURGERY ON (B)(6) 2023, CUT-OUT WAS CONFIRMED UNDER A TYPE. ALTHOUGH BLADE INSERTION DIRECTION WAS SLIGHTLY FORWARD, THE CAUSE OF CUT-OUT IS UNKNOWN. A REVISION SURGERY WAS SCHEDULED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16372064 ↗
• InjuryJun 27, 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 A SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, CUT-OUT OF THE BLADE AND NON-UNION WERE CONFIRMED. ON (B)(6) 2022, ALL THE IMPACTED PRODUCTS WERE EXTRACTED, AND A REVISION SURGERY WAS PERFORMED VIA BHA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14830820 ↗
• InjuryMay 7, 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 AN UNKNOWN DATE, THE PATIENT HAD A SHORT PFNA NAIL INSERTED SIX (6) MONTHS AGO AND WAS EXCHANGED WITH LONGER PFNA NAIL DUE TO MALUNION. THE REVISIONS SURGERY WAS PERFORMED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) UNKNOWN SCREWS: NAIL DISTAL LOCKING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 14320613 ↗
• InjuryApr 6, 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 (ORIF) WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM FOR THE FRACTURE OF THE TROCHANTERIC FEMUR. THE FRACTURE WAS INTRAMEDULLARY, AND THE PROXIMAL FRAGMENT DISPLACED POSTERIORLY. THE SURGEON TRIED TO REDUCE THE FRACTURE; HOWEVER, IT DID NOT GO WELL, AND THE FRACTURE WAS FIXED WITH SUBTYPE N (IKUTA CLASSIFICATION). THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. INTRAMEDULLARY FIXATION WAS OBSERVED A FEW DAYS AFTER THE SURGERY. RECENTLY, THE PATIENT COMPLAINED OF PAIN, AND IT WAS CONFIRMED THAT THE PSEUDOARTHROSIS OCCURRED. THE REVISION SURGERY FOR REMOVAL OF THE IMPLANTS AND THE TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone; Pain

  MAUDE report 14026669 ↗
• InjuryNov 24, 2021Adverse 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 IN (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE TFNA IMPLANTS IN QUESTION. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PATIENT HAD A RECENT FALL AND EXPERIENCED PAIN. THE PATIENT EXPERIENCED DIFFICULTY WALKED AND PRESENTED TO THE HOSPITAL. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED THE FEMORAL HEAD TO BE BROKEN. THE SURGEON DECIDED TO REMOVE THE TFNA IMPLANT AND PROCEED WITH REPLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REPLACEMENT SURGERY. THE IMPLANT WAS REMOVED AND THE PATIENT WAS PLANNED FOR BIPOLAR/TOTAL HIP REPLACEMENT. HOWEVER, INFECTION WAS FOUND IN THE PATIENT AND THE REPLACEMENT PROCEDURE DID NOT PROCEED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12870485 ↗
• InjuryOct 20, 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 RE-OPERATION DUE TO BEING NON-COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS WHICH RESULTED IN A NON-UNION FRACTURE. TITANIUM CANNULATED TIBIAL NAIL AND FOUR (4) LOCKING SCREWS WILL BE REMOVED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER CLOSE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12666386 ↗
• InjuryOct 1, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH TFNA SYSTEM IN QUESTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY ON AN UNKNOWN DATE, THE PATIENT FELL, AND THE IMPLANT WAS ABOUT TO BE CUT OUT. ON (B)(6), THE SURGEON WILL PERFORM A RE-SURGERY TO REMOVE THE TNFA SYSTEM AND REPLACE IT WITH S-ROM. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12563673 ↗
• InjurySep 16, 2021Adverse 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 THE TROCHANTERIC FEMUR FRACTURE WITH THE NAIL IN QUESTION. THE SURGEON INSERTED THE TFNA LONG NAIL WITH ATYPICAL FEMORAL DIAPHYSEAL FRACTURES. THE MEDULLARY CAVITY OF THE PATIENT WAS SMALL, SO THE SURGEON INSERTED THE REAMING ROD AND WAS REAMING UNTIL F11.5MM AND INSERTED THE NAIL (F10MM). THE SURGEON FINISHED REDUCTION, BOTH NAIL LENGTH AND BLADE DEPTH WERE GOOD. THE SURGEON USED TWO THE LOCKING SCREW FOR 1 STATIC LOCKING AND 1 DYNAMIC LOCKING. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT RETURNED TO HER DAILY LIFE WITHOUT ANY PAIN. HER WALKING ABILITY GRADUALLY DECLINED AND SHE FELT SEVERE PAIN A WEEK AGO. THE X-RAY SHOWED THAT THE NAIL WAS BROKEN, AND THERE WAS A PROBLEM WITH THE LATERAL CORTICAL BONE. THE SURGEON WILL PERFORM THE REVISION SURGERY ON (B)(6) 2021, AND REMOVE THE BROKEN NAILS AND THE TFNA LONG NAIL IMPLANT AGAIN. THE NAIL BROKE 3 MONTHS AFTER THE SURGERY, AND IS TOO EARLY. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM

  Patient problems: Pain

  MAUDE report 12484838 ↗
• MalfunctionAug 17, 2021Device-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 SURGERY FOR TROCHANTERIC FEMUR FRACTURE. DURING THE SURGERY, PFNA WAS IMPLANTED, AND THE DRILL BIT CAME INTO CONTACT WITH THE NAIL AND THE DISTAL LOCKING SCREW COULD NOT BE INSERTED WELL. THE SURGEON HANDLED THE DRILL BIT BUT COULD NOT INSERT THE LOCKING SCREW. THERE WAS AN AXIAL DEVIATION BETWEEN THE NAIL AND THE SLEEVE. THE SURGERY WAS COMPLETED WITHOUT INSERTING THE LOCKING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334111 ↗
• InjuryJul 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE SURGEON REPLACED A NEW TFN, HELICAL BLADE AND LOCKING SCREW. DUE TO LOSE OF HELICAL BLADE INSIDE THE NAIL, WHICH WAS CAUSING THE CUT OUT. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICE REPORTED: 170MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL: (PART# 456.318S; LOT# UNKNOWN; QUANTITY: 1) LOCKING SCREW 5.0MM (PART# 04.005.526S; LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173676 ↗
• MalfunctionApr 8, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA ) CONVERSION TO TOTAL HIP. TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS REMOVED DUE TO CUT OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633921 ↗
• MalfunctionFeb 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THERE WAS A ISSUE INSERTING THE 5MM DISTAL LOCKING SCREW WITH A SHORT TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL. THE 5MM DISTAL LOCKING SCREW SCREW MISSED THE HOLE IN THE TFNA NAIL AND WAS NOT ABLE TO BE REMOVED. THE SCREW WAS FIXED IN THE BONE. THEY ARE UNSURE IF THE AIMING ARM HAD LOOSENED DURING THE PROCEDURE. WITH THIS PARTICULAR COMPLAINT THERE IS NO IMPLANTS TO RETURN AS ALL ELEMENTS OF THE CONSTRUCT HAVE REMAINED IMPLANTED IN THE PATIENT. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); TFNA FEM NAIL Ø11 R 130° L235 TIMO15 (PART # 04.037.144S, LOT # 51P7275, QUANTITY 1); TFNA SCR PERF L110 TAN (PART # 04.038.210S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375366 ↗
• InjuryJan 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON IMPLANTED A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED HELICAL BLADE, TITANIUM LOCKING SCREW WITH T25 STARDRIVE, AND A 130 DEGREES TITANIUM CANNULATED. THE PATIENT DEVELOPED A RASH SHORTLY AFTER THE PROCEDURE. AS OF (B)(6) 2019, THE RASH HAD GONE AWAY. THE SURGICAL DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Rash

  MAUDE report 8281762 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) SYSTEM TITANIUM (TI) LOCKING SCREW BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE HIP ON (B)(6) 2018. THE SCREW HEAD BROKE OFF WHEN THE SURGEON COMPLETED THE INSERTION OF THE SCREW. THE SURGEON RETRIEVED THE BROKEN HEAD AND LEFT THE REMAINING PORTION OF THE SCREW IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES DUE TO THE SURGEON HAVING TO RETRIEVE THE BROKEN SCREW HEAD. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW WITH T25 STARDRIVE 36MM FOR INTRAMEDULLARY (IM) NAIL-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7773690 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, TO REMOVE FIVE (5) TITANIUM LOCKING SCREWS, AN 11MM TITANIUM CANNULATED TIBIAL NAIL AND A TITANIUM END CAP DUE TO DELAYED HEALING AND A NON-UNION. IT ORIGINAL IMPLANT DATE OF THE EXPLANTED DEVICES IS UNKNOWN AT THIS TIME. THE PATIENT WAS REVISED TO A LARGER 13MM TIBIAL NAIL AND USED A LOCKING SCREW ON THE LATERAL SIDE TO AID WITH PROPER REDUCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE. NO PATIENT OUTCOME REPORTED. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7546214 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, TFNA SCREW, AND 5.0MM LOCKING SCREW ON UNKNOWN DATE IN 2017. ON UNKNOWN DATE IT WAS REVEALED THE TFNA SCREW HAD CUT THROUGH THE LATERAL CORTEX OF THE FEMUR AS A RESULT OF A NON-UNION. THE CUT THROUGH RESULTED IN IRRITATION OF SOFT TISSUE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A TOTAL HIP CONSTRUCT. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7481015 ↗