BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 90MM STERILE

    MDR report key: 6594009 · Received May 26, 2017

    Report

    Report Number
    3003506883-2017-10092
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    April 30, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. PART 04.038.290S, LOT H202883: RELEASE TO WAREHOUSE DATE: NOVEMBER 15, 2016. EXPIRATION DATE: OCTOBER 31, 2026. MANUFACTURING SITE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 90 MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK BUT WITH ONE NONCONFORMANCE NOTED. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID: (B)(6). ALTHOUGH NO DEVICE WAS RETURNED TO CUSTOMER QUALITY (CQ) FOR EVALUATION, A REVIEW OF THE X-RAY IMAGE PROVIDED CONFIRMS THAT HELICAL BLADE HAD MIGRATED, PERFORATING THE FEMORAL HEAD AND INTO THE PELVIS. THEREFORE, THIS COMPLAINT IS CONFIRMED. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CQ IS NOT APPLICABLE FOR THIS CONDITION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. TABULATED PRODUCT DRAWING FOR THE FAMILY OF TITANIUM TFNA HELICAL BLADES WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED WITH AVAILABLE INFORMATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: CORRECTED THE REVISION SURGERY DATE IN THE DESCRIPTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL AND REVISION TO A TOTAL HIP PROSTHESIS ON (B)(6) 2017. INITIALLY, THE PATIENT WAS IMPLANTED ON (B)(6) 2017 WITH A RIGHT SHORT TROCHANTERIC NAIL AND A 90 MM HELICAL BLADE TO TREAT A RIGHT HIP FRACTURE. SUBSEQUENTLY, IT WAS DISCOVERED THAT THE HELICAL BLADE HAD MIGRATED, PERFORATING THE FEMORAL HEAD AND INTO THE PELVIS. THE MIGRATION WAS DIAGNOSED BY THE PATIENT COMPLAINING OF PAIN AND SUBSEQUENT IMAGES WERE TAKEN THAT SHOWED THE BLADE HAD MIGRATED. DURING THE REVISION, THE TROCHANTERIC NAIL, HELICAL BLADE AND SET SCREW WERE EASILY REMOVED AND INTACT. THE PATIENT WAS IMPLANTED WITH NON-SYNTHES AND DEPUY DEVICES. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES: TFNA (PART 04.037.142S, LOT H247687, QUANTITY 1), LOCKING SCREW (PART 04.005.528S, LOT H244729, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    PRIOR TO THE PATIENT HAVING REVISION SURGERY SHE HAD DIFFICULTY WALKING WITH ACUTE EXACERBATION OF GROIN PAIN. DURING THE REVISION SURGERY ON (B)(6) 2017 IT WAS NOTED THAT THE POSTERIOR ONE-HALF OF THE PATIENT'S GREATER TROCHANTER HAD NOT HEALED. ALSO, THE PATIENT HAD A LARGE ISOLATED CAVITARY DEFECT IN THE POSTERIOR SUPERIOR REGION OF HER ACETABULUM THAT WAS IMPACTED WITH BONE GRAFT FROM THE PATIENT'S FEMORAL HEAD.

    Description of Event or Problem · 1

    PRIOR TO THE PATIENT HAVING REVISION SURGERY SHE HAD DIFFICULTY WALKING WITH ACUTE EXACERBATION OF GROIN PAIN. DURING THE REVISION SURGERY ON (B)(6) 2017 IT WAS NOTED THAT THE POSTERIOR ONE-HALF OF THE PATIENT'S GREATER TROCHANTER HAD NOT HEALED. ALSO, THE PATIENT HAD A LARGE ISOLATED CAVITARY DEFECT IN THE POSTERIOR SUPERIOR REGION OF HER ACETABULUM THAT WAS IMPACTED WITH BONE GRAFT FROM THE PATIENT'S FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375740 TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA H202883

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention ONE PART 04.005.528S, LOT H244729, LOCKING SCREW