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TFN-ADVANCE 04.038.195SRecalls & reported problems

Synthes GmbH · TFNA FENESTRATED SCREW 95MM - STERILE · Class 2 · Implant

All models of TFN-ADVANCE (195)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
23
Deaths reported
0
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982098757), received between Jan 7, 2019 and Jan 26, 2026 — classified as 14 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility8
  • Break6
  • Adverse Event Without Identified Device or Use Problem3
  • Migration3
  • Material Twisted/Bent2
  • Migration or Expulsion of Device2

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • Failure of Implant5
  • No Code Available4
  • Pain3
  • Bone Fracture(s)1
  • Foreign Body In Patient1
  • Impaired Healing1
  • Insufficient Information1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 26, 2026Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CONDUCTING A TFNA, SURGEON ATTEMPTED TO PLACE A 95MM SCREW OVER OUR 3.2MM GUIDE WIRE AN IT WOULD NOT PASS. SURGEON TOOK THE SCREW OFF THE INSERTION HANDLE, PASSED THE 3.2 GUIDE WIRE INDEPENDENTLY THROUGH THE SCREW, SCREW INSERTED AND RETENTION PIN WITHOUT ISSUE. SURGEON THEN REASSEMBLED THE SCREW ONTO THE SCREW INSERTER WITH THE CONNECTING SCREW AND IT AGAIN DID NOT PASS. SURGEON OPENED ANOTHER TFNA LOCKING SET AND THE SAME ISSUE OCCURRED. SURGEON THEN OPENED A NEW 95MM TFNA SCREW AND IT WORKED WITHOUT ANY ISSUE. THERE WAS NO PATIENT IMPACT FOR THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24177864 ↗
  • MalfunctionJan 26, 2026Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CONDUCTING A TFNA, SURGEON ATTEMPTED TO PLACE A 95MM SCREW OVER OUR 3.2MM GUIDE WIRE AN IT WOULD NOT PASS. SURGEON TOOK THE SCREW OFF THE INSERTION HANDLE, PASSED THE 3.2 GUIDE WIRE INDEPENDENTLY THROUGH THE SCREW, SCREW INSERTED AND RETENTION PIN WITHOUT ISSUE. SURGEON THEN REASSEMBLED THE SCREW ONTO THE SCREW INSERTER WITH THE CONNECTING SCREW AND IT AGAIN DID NOT PASS. SURGEON OPENED ANOTHER TFNA LOCKING SET AND THE SAME ISSUE OCCURRED. SURGEON THEN OPENED A NEW 95MM TFNA SCREW AND IT WORKED WITHOUT ANY ISSUE. THERE WAS NO PATIENT IMPACT FOR THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24177841 ↗
  • InjuryJan 14, 2026Break

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO TFNA SCREW BREAKAGE. THE SCREW BROKE AT THE FENESTRATIONS.

    Patient problems: Insufficient Information

    MAUDE report 24068802 ↗
  • MalfunctionDec 29, 2025Break; Break

    IT WAS REPORTED A SCREW HAD CHIPPING THREADS. THE SURGEON CONFIRMED THAT HE ENCOUNTERED METAL CHIPPING WHILE INSERTING THE SCREW. HE REMOVED IT AND REPLACED IT WITH ANOTHER SIMILAR SIZE SCREW AND THE SURGERY WAS COMPLETED WITH OUT FURTHER ISSUES. SURGERY WAS DELAYED 10 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23909104 ↗
  • MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT THE SURGEON ENCOUNTERED ABRASION WHEN INSERTING THE FEMORAL NECK SCREW. THERE WAS A PROBLEM WITH ADVANCING THE SCREW - IT TOUCHED THE LATERAL PART OF THE NAIL. IT COULDN'T BE INSERTED SECURELY AND SAFE THROUGH THE LATERAL NAIL OPENING. ANOTHER IMPLANT (NAIL AND SCREW) WERE OPENED. FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNKNOWN LENGTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21618147 ↗
  • MalfunctionMar 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT WHILE PERFORMING THE CEMENTATION, IN THE FILLING OF THE SECOND 2ML SYRINGE, THE PLUNGER OF THE CEMENT SYRINGE EMITTED A SOUND, TO WHICH THE SPECIALIST MENTIONED THAT THEY HAD DAMAGED THE PLUNGER. IT WAS FILLING SLOWLY HOWEVER HE DIDN'T WAIT AND BEGAN TO MANEUVER IT, STATING THAT IT DID NOT WORK. AT THE END OF THE PROCEDURE IT WASN'T POSSIBLE TO SCREW THE CLAMPING SCREW. AFTER THIS THE EXTRACTION OF THE ENTIRE DEVICE WAS CARRIED OUT, AND AN ATTEMPT WAS MADE TO LOOSEN THE NAIL ON THE TABLE, BUT IT WAS IMPOSSIBLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21608241 ↗
  • InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT WAS SCHEDULED WITH A BROKEN FEMUR FRACTURE BELOW THE CURRENT IMPLANT. DOCTOR REMOVED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANTS WITHOUT ANY ISSUES - ALL HARDWARE WAS INTACT AND NOTHING WAS BROKEN. DOCTOR THEN IMPLANTED A NON-SYNTHES INTERTAN NAIL TO ADDRESS THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 95MM - STERILE.

    Patient problems: Limb Fracture

    MAUDE report 20280965 ↗
  • MalfunctionSep 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2024, THE DEVICE WON'T RETAIN WITH COUPLING SCREW. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20147286 ↗
  • InjurySep 19, 2023Migration; Migration

    A HELICAL BLADE WAS NOT USED DURING THE PRELIMINARY OR THE REMOVAL PROCEDURE.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 17772574 ↗
  • MalfunctionAug 16, 2023Material Twisted/Bent; Material Twisted/Bent

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AUGUST 2, 2023, CONNECTION TO LAG SCREW CROSS THREADING RESULTED IN DAMAGE TO LAG SCREW INSERTER AND TO THE IMPLANT ON INSERTION. A SECOND SET WAS OPENED AND A NEW IMPLANT WAS USED, CONTINUED WITHOUT FURTHER ISSUE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIE(5) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17556231 ↗
  • InjuryFeb 7, 2023Break; Break

    IT WAS REPORTED THAT A FOLLOW-UP X-RAY REVEALED A BROKEN BLADE AND TFNA NAIL. SURGERY TO IMPLANT THE DEVICES OCCURRED ON (B)(6) 2022. SURGERY WENT WELL AND PATIENT WAS DOING FINE, THEN SHOWED UP WITH A BROKEN LAG SCREW APPROXIMATELY IN (B)(6). PATIENT DID REPORT A FALL. PAIN CAME ON SUDDENLY AND PATIENT FELT LIKE SHE BROKE HER HIP AGAIN. X-RAYS REVEALED LAG SCREW BROKE. REVISION SURGERY OCCURRED ON (B)(6) 2023 WITH A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WENT WELL AND ALL IMPLANTS WERE RECOVERED.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16311075 ↗
  • InjuryDec 30, 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 REVISION SURGERY OF THE TFNA IMPLANTS IN QUESTION DUE TO FRACTURE DISPLACEMENT. THE ORIGINAL IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: Bone Fracture(s)

    MAUDE report 13118353 ↗
  • MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT IS SCHEDULED FOR TFNA REVISE DUE TO FRACTURE DISPLACEMENT. DURING EXTRACTION THE NAIL WAS VERY DIFFICULT TO CONNECT THE EXTRACTOR. THE SET SCREW WAS BACK OUT ENOUGH TO REMOVE THE LAG SCREW AND THE SMITH AND NEPHEW CONICAL EXTRACTOR WAS CONNECTED AND THE NAIL WAS SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 95MM - STERILE THIS REPORT IS 3 OF 3 FOR PC-(B)(4). RELATED PRODUCT COMPLAINT: PC-(B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13113600 ↗
  • InjuryJul 29, 2021Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL PROCEDURE DUE TO BROKEN TFNA FENESTRATED SCREW. IT WAS NOTED THAT THE TFNA LAG SCREW BROKE INSIDE A PATIENT AFTER HEALING. THERE WAS NO BROKEN FRAGMENT GENERATED AND NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS FOR A TFNA LAG SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 12246844 ↗
  • InjuryFeb 3, 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 A REMOVAL DUE TO THE MALREDUCTION OF THE ORIGINAL SURGERY. THE ORIGINAL SURGERY WAS DONE AT THE END OF (B)(6) 2020. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FEMORAL NAIL, FEMORAL NECK SCREWS, PERFORATED AND 5.0MM TI LOCKING SCREW WERE REMOVED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: Malunion of Bone

    MAUDE report 11275109 ↗
  • InjuryDec 21, 2020Migration; Migration

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT SHOWED IN THE OFFICE COMPLAINING OF HIP PAIN AND IT WAS THOUGHT THAT SHE HAD FALLEN. THE X-RAY SHOWED THAT THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) THAT WAS IMPLANTED ON (B)(6) 2020, HAD CUT OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE TOTAL HIP REPLACEMENT. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE (PART NUMBER 04.037.244S, LOT 34P7508, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART NUMBER 04.005.528, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 TFNA FENESTRATED SCREW 95MM ¿ STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: Pain

    MAUDE report 11049876 ↗
  • InjurySep 22, 2020Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED SCREW. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TFNA FENESTRATED HELICAL BLADE, TFNA NAIL AND LOCKING SCREWS ON AN UNKNOWN DATE. IMPLANTED DEVICES COMPLETELY REMOVED. THE OTHER MEDICAL INTERVENTION REQUIRED IS HEMI HIP ARTHROPLASTY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 10567864 ↗
  • InjuryJun 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. THE LAG SCREW WAS PROTRUDING OUT OF LATERAL CORTEX WHICH WAS CAUSING PAIN TO THE PATIENT. THE SURGEON EXCHANGED THE LAG SCREW WITH A SHORTER LAG SCREW. THE SET SCREW WAS BACKED OUT, THE ORIGINAL LAG SCREW REMOVED, AND A SHORTER LAG SCREW WAS INSERTED FOLLOWING WITH THE SET SCREW GOING BACK DOWN. THE ORIGINAL CASE WAS PERFORMED APPROXIMATELY 6 MONTHS PRIOR TO REVISION SURGERY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS AND OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN NAILS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Code Available; Pain

    MAUDE report 10190918 ↗
  • InjuryFeb 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS FURTHER REPORTED THAT THE FENESTRATED LAG SCREW WAS NEVER PLACED THROUGH THE NAIL. THERE WAS NO ALLEGATION AGAINST THE NAIL. CONCOMITANT DEVICE REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART NUMBER: 04.005.530, LOT NUMBER: UNKNOWN, QUANTITY: 1); 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE (PART # 04.037.130S, LOT # H847439, QUANTITY 1).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 9746866 ↗
  • InjuryFeb 3, 2020Migration; Migration

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT IMPLANT REMOVAL AND CONVERSION TO TOTAL HIP DUE TO THE FENESTRATED SCREW PROTRUDED THROUGH THE FEMORAL HEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: UNKNOWN); UNKNOWN END CAP (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); TFNA NAIL (PART#: 04.037.157S, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 9659656 ↗
  • InjuryNov 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY OF A SHORT TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) NAIL DUE TO A LATERAL PROTRUSION OF THE LAG SCREW ON AN UNKNOWN DATE. ORIGINALLY, THE PATIENT WAS ORIGINALLY IMPLANTED IN (B)(6) 2019. THE PATIENT WAS SUFFERING OF LENGTH DISCREPANCY FROM COLLAPSED. THE TFNA WAS REMOVED AND EXCHANGED FOR A TOTAL JOINT. TFNA NAIL, LAG SCREW, AND DISTAL LOCKING SCREW REMOVED WITHOUT INCIDENT. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART# 04.037.112S, LOT# H759956, QUANTITY# 1). DISTAL LOCKING SCREW (PART# 04.005.526S, LOT# H772128, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Patient problems: No Code Available

    MAUDE report 9268154 ↗
  • InjurySep 4, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) FENESTRATED SCREW AND DISTAL LOCKING SCREW ON (B)(6) 2019. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE TFNA DUE TO A RIGHT PROXIMAL FEMUR FRACTURE IN (B)(6) 2018. ON AN UNKNOWN DATE AFTER THE ORIGINAL SURGERY, THE PATIENT PRESENTED FOR TREATMENT OF NON-UNION OF RIGHT PROXIMAL FEMUR. THE THREADED PORTION OF THE LAG SCREW BROKE DEEP WITHIN THE BONE AND A DECISION WAS MADE TO LEAVE IT. ADDITIONALLY, THE DISTAL LOCKING SCREW WAS ALSO FOUND BROKEN AND A DECISION WAS ALSO MADE TO NOT RETRIEVE THE FRAGMENTS. THE NAIL AND A MAJORITY OF THE LAG SCREW WERE REMOVED AND REPLACED WITH AN ANGLE BLADE PLATE. THE IMPLANTS AND SPECIMENS WERE SENT TO PATHOLOGY FOR ROUTINE CULTURE AND RULE OUT INFECTION. HOWEVER, THE SUSPECTED CAUSE OF THE NON-UNION WAS A POOR REDUCTION FROM THE ORIGINAL SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART # 04.037.158S, LOT # UNKNOWN, QUANTITY# 1). THIS IS REPORT 2 FOR 2 (B)(4).

    Patient problems: Foreign Body In Patient; Impaired Healing

    MAUDE report 8961320 ↗
  • MalfunctionJan 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) PROCEDURE, THE SURGEON HAD DIFFICULTY INSERTING THE LAG SCREW DUE TO THE HELICAL BLADE/SCREW COUPLING SCREW AND INSERTION HANDLE BECAME CROSS THREADED DURING INSERTION. IT WAS UNKNOWN IF OTHER DEVICES WERE USED, BUT THE LAG SCREW WAS SUCCESSFULLY INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TFNA FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8223630 ↗

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

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Sources and updates

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