BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M CRIMP TOOL

    MDR report key: 2707501 · Received August 14, 2012

    Report

    Report Number
    2249697-2012-01202
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF 'D/M CRIMP TOOL' WAS BROKEN DURING CRIMPING THE SLEEVE IN BHA. THE BROKEN TIP WAS NOT REMAINED IN THE PT AND DISCARDED. THE SURGEON SAID, THE SLEEVE COULD BE CRIMPED WELL, SO THERE WS NO ADVERSE CONSEQUENCES. ALSO, THERE WAS ANY DELAY FOR THE OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D/M CRIMP TOOL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other