BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP F/CORTSCR Ø4.5 L125/70

    MDR report key: 3092245 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02109
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RECEIVED DATE REPORTED IN ERROR. DEVICE HAS NOT BEEN RECEIVED. DEVICE IS A MULTIUSE INSTRUMENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPERATION ON A DYNAMIC HIP SCREW (DHS) PATIENT ON (B)(6) 2013, THE TIP OF THE TAP WAS BROKEN DURING NORMAL USE. THE BROKEN TIP OF THE TAP REMAINED IN THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195361 TAP F/CORTSCR Ø4.5 L125/70 HWX SYNTHES GMBH SER.NR. 2073

    Patients

    Seq Age Sex Outcome Treatment
    1