TFN-ADVANCE 04.038.400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982099297), received between Sep 13, 2019 and Aug 3, 2026 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K160167); they may or may not involve this specific model.

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113813 ↗
• InjuryJun 11, 2026Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL FRACTURE WITH THE PRODUCT IN QUESTION. AFTER SURGERY, IT WAS OBSERVED THAT THE POSITION OF THE BLADE HAD SHIFTED APPROXIMATELY 20MM. THE BLADE WAS REMOVED ON (B)(6) 2026. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25471247 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS NOT POSSIBLE TO UNLOCK THE SYSTEM TO REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 24168022 ↗
• InjuryDec 2, 2025Migration; Migration

  THE PATIENT UNDERWENT AN ORIF SURGERY FOR FEMORAL NECK FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT SUBSEQUENT X-RAYS REVEALED EXCESSIVE TELESCOPING AND MIGRATION OF THE BLADE TO THE END OF THE FEMORAL HEAD, FOLLOWED BY A BLADE CUT-OUT. ALTHOUGH THE PATIENT WAS NOT EXPERIENCING PAIN AT THE TIME OF REPORTING, THERE WAS A HIGH RISK OF ACETABULAR DAMAGE AND PROGRESSION OF OSTEOARTHRITIS IF THE CUT-OUT WORSENED. REVISION SURGERY WAS SCHEDULED TO REPLACE THE TFNA IMPLANTS WITH AN ARTIFICIAL FEMORAL HEAD OR PERFORM A TOTAL HIP ARTHROPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 23693284 ↗
• InjuryJun 16, 2025Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE BLADE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE SURGEON REPLACED THE BLADE (100MM) TO THE FEMORAL NECK SCREW (90MM), BECAUSE THE BLADE WAS ALMOST GETTING PERFORATION OF THE FEMORAL HEAD. PRIMARY SURGERY WAS ON (B)(6) 2025. THE SURGEON SHARED THAT THE BLADE WAS A BIT LONG AT THE PRIMARY SURGERY, SO THE SURGEON WAS FOLLOWING THE PATIENT CAREFULLY WITH A PERIOD OF WEIGHT-FREE SURGERY. HOWEVER, WHEN THEY TOOK AN X-RAY THE OTHER DAY THE SURGEON NOTICED THAT THE TIP OF THE BLADE WAS ADJACENT TO THE SUBCHONDRAL BONE OF THE FEMORAL HEAD, SO THE SURGEON DECIDED TO REPLACE THE HEAD ELEMENT ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22215938 ↗
• InjuryMar 12, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TFNA NAIL BROKE INSIDE THE PATIENT. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Fall

  MAUDE report 18885907 ↗
• InjuryOct 18, 2023Migration; Migration

  UPDATED INCIDENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN POSTOPERATIVE DATE, A PATIENT'S TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HAD SLIPPED. THE IMAGES THAT WERE PROVIDED SHOWED THAT THE TFNA HELICAL BLADE HAD SLIPPED NOT THE NAIL. FURTHER IT WAS REPORTED THAT INITIALLY PATIENT HAD PERTROCHANTULAR FEMORAL FRACTURE LEFT AFTER A FALL TO THE LEFT HIP AND WAS IMPLANTED WITH TFNA SYSTEM ON (B)(6), 2023. PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2023 DUE TO DISLOCATION TO CAUDAL TOWARD SMALL PELVIS. NO FALL RECOLLECTED. THE TFNA HELICAL BLADE WAS REMOVED. AFTER REPOSITIONING THE FRACTURE, A NEW TFNA HELICAL BLADE PERFORATED 90MM WAS INSERTED. SUBSEQUENTLY, ON (B)(6) 2023 THERE WAS A FURTHER DISLOCATION OF THE HELICAL BLADE TOWARD CAUDAL TOWARD THE SMALL PELVIS (NO FALL REMEMBER), SO THAT THE HELICAL BLADE FROM (B)(6) 2023 AS WELL AS THE TFNA INTRAMEDULLARY NAIL SYSTEM WERE COMPLETELY REMOVED. IN THE COURSE OF THIS REVISION OPERATION, A CEMENTED TOTAL ENDOPROSTHESIS FROM DEPUY JOHNSON AND JOHNSON WAS IMPLANTED. (CORAIL SHAFT CEMENTED, SIZE 12, 150 MM, PINNACLE PANNE SIZE 48, NON-CEMENTED, PINNACLE SPONGIOSA SCREW, CANNULATED L50). THIS REPORT CAPTURES THE REVISION SURGE

  Patient problems: Insufficient Information

  MAUDE report 17958145 ↗
• MalfunctionAug 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE 125 DEGREE AIMING ARM AND 125 DEGREE NAIL WAS USED BUT THE HELICAL BLADE DID NOT FULLY INSERT THROUGH THE NAIL, THE NAIL WOULD NOT COMPLETE THE INSERTION. SO EVERYTHING WAS REMOVED AND THEY ENDED UP USING A NEW NAIL AND NEW HELICAL BLADE AND THEN EVERYTHING WORKED PERFECTLY. THIS REPORT IS FOR TFNA FENESTRATED HELICAL BLADE 100 -S FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605489 ↗
• MalfunctionAug 18, 2023Migration; Migration

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE HELICAL BLADE WAS COMPLETELY LOCKED DOWN USING THE LOCKING MECHANISM AND IT STILL BACKED OUT. NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST OPERATIVE ASSESSMENT ON AUGUST 1, 2023 NOTED THE FOLLOWING. THERE IS "SLIGHT SHORTENING AT THE FRACTURE SITE NOTED ON RADIOGRAPHS. HE IS DOING WELL OVERALL, AND THIS WILL LIKELY NOT BE OF MAJOR CLINICAL SIGNIFICANCE. IT SHOULD BE NOTED THAT THE INTERFERENCE SCREW WAS FULLY TIGHTENED DURING THIS CASE TO PREVENT DYNAMIC SHORTENING, PER MANUFACTURER SPECIFICATION. REVIEW OF THE INTRAOPERATIVE C-ARM IMAGES DEMONSTRATE THIS AS WELL, HOWEVER, DYNAMIC SHORTENING DID OCCUR IN THIS CASE." THIS COMPLAIN INVOLVES ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573156 ↗
• InjuryJul 14, 2023Break; Break

  NO X-RAY OR CT SCANS ARE AVAILABLE. IMPLANT DATE IS UNKNOWN. EXPLANT DATE WAS (B)(6)2023.

  Patient problems: Pain

  MAUDE report 17326781 ↗
• MalfunctionJun 27, 2023Difficult to Advance; Difficult to Advance

  IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THERE HAS BEEN NO REVISION YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208048 ↗
• InjurySep 23, 2022Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON REMOVED A 100MM FENESTRATED HELICAL BLADE AND REPLACED IT WITH AN 80MM SCREW. THE HELICAL BLADE HAD PENETRATED THE FEMORAL HEAD INTO THE JOINT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15469545 ↗
• InjuryJul 14, 2022Migration; Migration

  IT WAS REPORTED THAT WHILE INSERTING THE HELICAL BLADE, THE SURGEON PERFORATED THE FEMORAL HEAD. THE HELICAL BLADE WAS BACKED OUT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS SOME PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 15017351 ↗
• InjuryApr 6, 2022Migration; Migration

  IT WAS FURTHER REPORTED THE HELICAL BLADE COMES OUT OF THE NAIL AND THE FEMORAL NECK BROKE. THE IMPLANTS WERE IN THE PATIENT APPROXIMATELY 1 MONTH. ORIGINAL IMPLANT DATE WAS (B)(6), 2022. A REVISION SURGERY WAS SCHEDULED AND COMPLETED ON (B)(6), 2022. HARDWARE WAS REMOVED AND NO BROKEN FRAGMENTS REMAINED IN THE PATIENT. IT IS UNKNOWN WHAT THE PATIENT WAS REVISED TO OR IF THERE WAS SURGICAL DELAY IN THE REVISION SURGERY.

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

  MAUDE report 14027057 ↗
• InjuryMar 20, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) , 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. AFTER SURGERY, IN (B)(6), 2022, THE PATIENT HAD A REAR-END ACCIDENT WHILE DRIVING. A WEEK AFTER THE ACCIDENT, THE PATIENT VISITED THE HOSPITAL WITH A COMPLAINT OF PAIN AND WAS EXAMINED. AS A RESULT, A CUT-OUT WAS FOUND. ON (B)(6), 2022, THE REVISION SURGERY VIA THA WILL BE PERFORMED. THE SURGEON COMMENTED THAT THIS CUT-OUT WAS LIKELY UNRELATED TO THE PRODUCTS AND CAUSED BY THE TRAFFIC ACCIDENT AND WALKING AFTER THE ACCIDENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13830583 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY WITH A PREVIOUSLY IMPLANTED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL AND HELICAL BLADE. POSTOPERATIVE X-RAY FROM THE ORIGINAL CASE SHOWS TFNA FENESTRATED HELICAL BLADE POSTERIOR OUTSIDE OF TFNA NAIL CAUSING LOSS OF REDUCTION. DURING THE REVISION SURGERY, THE OLD HELICAL BLADE WAS REMOVED AND A NEW HELICAL BLADE WAS IMPLANTED SUCCESSFULLY. PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN NAIL DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 13191302 ↗
• InjurySep 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A PROCEDURE DUE TO A BROKEN TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL. THE NAIL BROKE AT THE HELICAL BLADE/NAIL INTERFACE SIX MONTHS AFTER IMPLANTATION. THE INITIAL FRACTURE WAS AN INTERTROCHANTERIC WITH SUBTROCHANTERIC EXTENSION. THE BROKEN HARDWARE WAS REMOVED, AND THE NON-UNION SITE WAS REVISED WITH RIA BONE GRAFT AND AN ANGLED BLADE PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A TFNA HELICAL BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12526108 ↗
• InjuryAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). HELICAL BLADES, PERFORATED, STERILE (PART:04.038.400S; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 12393682 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO NON-UNION. THE NAIL AND BLADE WERE REMOVED AND REVISE TO DHS. PROCEDURE AND PATIENT OUTCOME WAS SUCCESSFUL.   THIS REPORT IS FOR 1 TFNA FENESTRATED HELICAL BLADE 100MM - STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11942595 ↗
• InjuryApr 13, 2021Migration; Migration

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA FENESTRATED HELICAL BLADE AND TITANIUM LOCKING SCREW DUE TO MIGRATION OF UNKNOWN IMPLANT AND THE SURGEON SAID IT WAS BEGINNING TO CUT OUT. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL ( PART # 04.037.156S, LOT# UNKNOWN, QUANTITY 0). UNKNOWN LOCKING SCREWS (PART# 04.005.532, LOT# UNKNOWN, QUANTITY 0). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11660379 ↗
• InjuryDec 5, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTED AND IT CUT OUT TWO TO THREE WEEKS LATER, BLADE CUT OUT OF HEAD. THE PATIENT WAS BROUGHT BACK FOR REMOVAL AND CONVERSION TO A JOINT REPLACEMENT. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME WAS UNKNOWN. PATIENT CONSEQUENCE PATIENT HAD A TFNA IMPLANTED AND IT CUT OUT 2-3 WEEKS LATER. THE PATIENT WAS BROUGHT BACK FOR REMOVAL AND CONVERSION TO A JOINT REPLACEMENT. CONCOMITANT DEVICES REPORTED: 10MM/130 DEG TI CANN TFNA 170MM - STERILE (PART# 04.037.042S, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DEPTH GAUGE FOR SMALL SCREWS. THIS REPORT IS 1 OF 1 FOR (B)().

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950863 ↗
• InjuryAug 18, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FEMUR REVISION DUE TO NON-UNION AND BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL. THE PATIENT'S STATUS WAS GOOD AND A NEW PROXIMAL FEMORAL NAILING SYSTEM (TFNA) WAS IMPLANTED. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE EASILY REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10420092 ↗
• MalfunctionMar 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOPEDIC PROCEDURE, THE SURGEON EXPERIENCED COMPLICATIONS WHILE USING THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DEVICES. DIFFICULTIES WERE ENCOUNTERED WHILE USING THE STEPPED DRILL BIT IN PREPARATION FOR THE HELICAL BLADE. AFTER DRILLING, THE SURGEON PROCEEDED TO INSERT THE HELICAL BLADE COMPONENT, WHICH WAS DIFFICULT TO INSERT. THE SURGEON PROCEEDED TO INSERT THE DISTAL LOCKING SCREW AND HAD COMPLICATIONS WITH INSERTING IT. AFTERWARDS THE SURGEON NOTICED THAT AN INCORRECT AIMING ARM (125 DEGREE) WAS UTILIZED. THE TFNA NAIL THAT WAS IMPLANTED WAS A 130 DEGREE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART 04.037.142S, LOT UNKNOWN, QUANTITY 1), CANNULATED STEPPED DRILL BIT (PART 03.037.022, LOT UNKNOWN, QUANTITY 1), THREE-FLUTED DRILL BIT (PART 03.010.061, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER (PART 04.005.532S, LOT UNKNOWN, QUANTITY 1), GUIDES/SLEEVES/AIMING: AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 100MM ¿ STERILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889260 ↗
• InjurySep 13, 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 A HARDWARE REMOVAL AND TOTAL HIP ARTHROPLASTY DUE TO AN ADVANCED LEFT HIP OSTEOARTHRITIS WITH RETAINED HARDWARE FROM A PREVIOUS FRACTURE AND SIGNS OF AVASCULAR NECROSIS WITH EARLY COLLAPSE OF THE FEMORAL HEAD. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) DUE TO NON-DISPLACED LEFT HIP INTERTROCHANTERIC FEMUR FRACTURE IN (B)(6) 2018. HOWEVER, SIX (6) MONTHS AFTER THE IMPLANT SURGERY, THE PATIENT FAILED CONSERVATIVE MEASURES, INCLUDING ANTI-INFLAMMATORIES AND PAIN MEDICATIONS. MOREOVER, THE PATIENT ALSO HAD AN INTRA-ARTICULAR INJECTION WITHOUT RELIEF OF HIS PAIN AND THEN WAS ADMITTED TO THE HOSPITAL TO HAVE THE HARDWARE REMOVED AND CONVERTED TO A TOTAL HIP ARTHROPLASTY. THE SURGEON NOTED THAT THE LOCKING MECHANISM AND HOLE FOR THE HELICAL BLADE IN THE TFNA NAIL WAS BENT AND DEFORMED AND AN INSPECTION SHOWED A LARGE NOTCH ANTERIORLY. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: REAMING ROD (PART# 351.706S, LOT# H564327, QUANTITY# 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Arthritis; Necrosis; No Code Available; Pain

  MAUDE report 9032953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S