BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3133573 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02455
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT PARTS WERE INSPECTED AND CONFORMED TO SYNTHES INCOMING FINAL INSPECTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ACCORDING TO THE ADDITIONAL EVALUATION (SERVICE HISTORY REVIEW), THE ITEM WAS RECEIVED WITH THE PRONG TIP MISSING. NO SERVICE HISTORY CAN BE PERFORMED BECAUSE THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE COMPLAINED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT THAT THE PRONGS TIP WAS MISSING ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON A PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235042 STANDARD INSERTION HANDLE LXH SYNTHES GMBH 1565419

    Patients

    Seq Age Sex Outcome Treatment
    1