BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM-STERILE

    MDR report key: 5798972 · Received July 15, 2016

    Report

    Report Number
    3003506883-2016-10119
    Event Type
    Injury
    Date Received
    July 15, 2016
    Report Date
    July 3, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DATE OF EVENT: UNKNOWN. ADDITIONAL PRODUCT CODE: HWC. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURE DATE: JULY 20, 2015. EXPIRATION DATE: JUNE 30, 2024. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9840315 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO AN 11.0MM TITANIUM HELICAL BLADE 90MM CUTTING OUT SUPERIORLY. PATIENT UNDERWENT INITIAL TROCHANTERIC FIXATION NAIL (TFN) SURGERY DUE TO A FALL ON (B)(6) 2016. NO REPORTED ISSUES DURING INITIAL SURGERY. IT IS UNKNOWN HOW THE CUT OUT WAS DISCOVERED. THE NAIL WAS EASILY REMOVED. REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS. PATIENT WAS REVISED TO A DEPUY HEMIARTHROPLASTY. PATIENT WAS REPORTED AS DOING WELL. CONCOMITANT DEVICE REPORTED: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT (PART 456.352S, LOT 5614495, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453235 11.0MM TI HELICAL BLADE 90MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9840315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention