BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICPROBE Ø3.7 W/SILIC HAND L240 F/PEDI

    MDR report key: 3202817 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01761
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND NOT IMPLANTABLE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND THE PARTS MET THE REQUIRED SPECIFICATIONS. NO COMPLAINT RELATED ISSUES WERE FOUND.(B)(4)

    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 A PROCEDURE ON AN UNKNOWN DATE, THE PLATE OF THE AWL BROKE OFF. IN ADDITION, THE THREAD OF THE RETAINING SLEEVE BROKE OFF. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301142 PEDICPROBE Ø3.7 W/SILIC HAND L240 F/PEDI HXB SYNTHES MONUMENT 6609676

    Patients

    Seq Age Sex Outcome Treatment
    1