BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN 3TI DRILL ATTACHM, LARGE JACOBSACCULAN

    MDR report key: 3810479 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00241
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE INVESTIGATION SHOWED THAT THREE TEETH OF THE DRILL ATTACHMENT ARE BROKEN OFF. THE ATTACHMENT ITSELF IS IN A USED CONDITION AND SHOWS NORMAL WER MARKS WHICH ARE CONSISTENT WITH USAGE MARKS. A CAPA HAS PREVIOUSLY BEEN INITIATED REGARDING THE DRILL ATTACHMENT AND BREAKING TEETH. RESULTING FROM THE CAPA, A CORRECTIVE ACTION WAS INITIATED. INVOLVEMENT COMPONENT: GA031201/WRENCH. THE INSPECTION OF THE WRENCH SHOWED SLIGHT DAMAGES AT THE TEETH. HOWEVER, AS THE DAMAGES ARE VERY MINIMAL, A CORRECT AND FULL FUNCTION OF THE WRENCH IS STILL GIVEN.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING SURGICAL PROCEDURE OF FEMUR NECK FIXATION, WHEN THE THIRD GUIDE WIRE WAS INTRODUCED IN THE FEMUR HEAD THE OPERATOR ASKED FOR A KEY TO SCREW IT OFF SO A CONTROL IMAGE COULD BE CAPTURED, AFTER THIS ACTION THE GUIDE WIRE SHOULD BE RE-SECURED. DURING SCREWING ON THE GUIDE WIRE, A METALLIC SOUND FROM INSIDE THE DRILL WAS EMITTED. INSPECTION OF THE DRILL REVEALED TWO TEETH OF THE DRILL ATTACHMENT WERE MISSING. ALL PARTS SPILLED OUT BEYOND THE OPERATING FIELD. THE WOUND WAS IRRIGATED AND IMAGING WAS COMPLETED. IMAGING CONFIRMED THAT NO FRAGMENTS REMAINED IN THE PATIENTS BODY. PROCEDURE WAS DELAYED APPROXIMATELY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234047 ACCULAN 3TI DRILL ATTACHM, LARGE JACOBSACCULAN DRILL ATTACHMENT FOR ORTHOPEDICS HWE AESCULAP AG & CO. KG GB638R 51986069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other