BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL Ø14/3.2 CANN

    MDR report key: 3173844 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03403
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 5, 2011
    Report Date
    June 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE TIP IS INDEED BROKEN OFF AS COMPLAINED (SEVERAL BITS). WE FOUND MARKS OF HAMMER BLOWS ON THE HANDLE WHICH INDICATE THAT THIS AWL WAS SUBJECTED TO INAPPROPRIATE HANDLING. THEREFORE WE DO SUPPOSE THAT THE CAUSE OF THIS BREAKAGE WAS DUE TO TOO HIGH MECHANICAL FORCE. THE FRACTURE AREA IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AWL CRACKED WHEN OPENING THE MEDULLARY CANAL. KIRSCHNER WIRE WAS INSERTED AND THE AWL WAS GUIDED FOR IT. THIS OCCURRED DURING AN OPERATION ON A (B)(6) MAN WITH A VERY THICK CORTEX. ALL BROKEN PARTS WERE RETRIEVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272874 AWL Ø14/3.2 CANN HWJ SYNTHES GMBH 1673468

    Patients

    Seq Age Sex Outcome Treatment
    1