BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT BROACH HANDLE

    MDR report key: 4223654 · Received August 5, 2014

    Report

    Report Number
    9614497-2014-00208
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER, THAT THE DEVICE WILL BE RETURNED TO (B)(4) MEDICAL FOR EVALUATION. ONCE (B)(4) MEDICAL RECEIVED THE DEVICE AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE TWO LOCKING DOWELS ARE MISSING AND HAVE FAILED AT THE WELD. ONE OF THE EDGES AROUND THE LOCKING DOWEL PIN RELEASE IS SCRATCHED AS IF IT HAS BEEN PRIED OR STRUCK. THE SEAT WHERE THE LATCHING MECHANISM RESIDES IS DEFORMED AND INDENTED AT THE LATCH SLOT CORNERS. IF THE SAMPLE WAS PRIED ALONG THE LATCH EDGE, THIS COULD CRACK THE WELDS WHICH WOULD EXPLAIN THIS TYPE OF FAILURE. IT IS UNKNOWN HOW THE REPORTED EVENT OCCURRED. DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. NO FURTHER INVESTIGATION REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER EMAIL RECEIVED (B)(6) 2014: CUSTOMER REPORTS; BOTH LOCKING DOWELS HAVE BROKEN OFF, SUCH THAT THE LOCKING LEVER IS NO LONGER RETAINED IN THE BODY OF THE INSTRUMENT. THE EVENT OCCURRED DURING A ROUTINE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR ADVERSE EVENTS. CUSTOMER INDICATED THAT THE LOCATION OF THE MISSING COMPONENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456370 STRAIGHT BROACH HANDLE BROACH HANDLE LXH GREATBATCH MEDICAL SA 450-04-01 66985

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK