BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEFT A/S BROACH HANDLE

    MDR report key: 3092463 · Received April 26, 2013

    Report

    Report Number
    9614497-2013-00001
    Event Type
    Other
    Date Received
    April 26, 2013
    Date of Event
    January 21, 2013
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THESE PARTS WERE MANUFACTURING BY PRECISION MEDICAL TECHNOLOGIES. THE DEVICE HISTORY RECORD WAS PULLED AND REVIEWED. IT WAS NOTED THAT AFTER THE REVIEW OF THE DHR FOR LOT NUMBER 56474893, THE PRODUCT WAS MANUFACTURED TO PRINT SPECIFICATION. THE MANUFACTURING PROCESS DID NOT SHOW ANY EVIDENCE THAT WOULD OF CAUSED THE ISSUE EXPERIENCED.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    THE FEMUR WAS BEING BROACHED WITH A SIX 13 TM HIP BROACH. WHEN THE PHYSICIAN WENT TO EXTRACT THE BROACH ((B)(4)), THE HANDLE POPPED OFF IN THE LOCKED POSITION AND HIT THE FLOOR. AFTER A 20 MIN FLASH IN THE AUTOCLAVE THE SAME INCIDENT OCCURRED ONCE MORE. CUSTOMER HAD TO WAIT FOR ANOTHER ANTERIOR HANDLE TO BE DELIVERED FROM AN ALTERNATE FACILITY IN ORDER TO COMPLETE THE CASE. THE CASE WAS DELAYED A TOTAL OF 1 HOUR AND 20 MINUTE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181620 LEFT A/S BROACH HANDLE LEFT A/S BROACH HANDLE HTQ GREATBATCH MEDICAL, INC. 00-7808-035-21 56474893

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other