BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM

    MDR report key: 5100160 · Received September 24, 2015

    Report

    Report Number
    3003506883-2015-10144
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    September 11, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT PROVIDED BY REPORTER. EVENT DATE: UNKNOWN WHEN PAIN BEGAN . THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ PART MFG DATE: 06/05/2015. PART EXP. DATE:04/30/2024. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7995539 OF 11.0MM TI HELICAL BLADE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS 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. COMMENTS: A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7945906) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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 WENT FOR REVISION SURGERY FOR A HIP FRACTURE (SIDE UNKNOWN) ON (B)(6) 2015 DUE TO THE TROCHANTERIC FIXATION NAIL SYSTEM'S (TFN) 90MM HELICAL BLADE PROTRUDED THROUGH THE FEMORAL HEAD. THE PATIENT WAS EXPERIENCING HIP PAIN AND WENT FOR A FOLLOW-UP DOCTOR'S APPOINTMENT WHERE IT WAS DISCOVERED BY AN X-RAY THAT THE BLADE HAD PENETRATED THROUGH THE FEMORAL HEAD. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2015. A PLANNED EXPLANT WAS SCHEDULED FOR (B)(6) 2015. THE PATIENT WAS IMPLANTED WITH AN 80MM HELICAL BLADE. THERE WAS NO SURGICAL TIME DELAY AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631016 11.0MM TI HELICAL BLADE 90MM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 7995539

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention