BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNEX W/SMALL END-PL H28-40 -5° TAN GREE

    MDR report key: 3072955 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01872
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 12, 2012
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    K003836
    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 MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE IMPLANT WORKS ABSOLUTELY FINE. THE IMPLANT ROD COULD GET DISTRACTED WITHOUT PROBLEMS. A FUNCTIONAL TEST WITH THE MIS AND THE EXPANDING COLLET SHOWED NO DEVIATIONS TO OUR SPECIFICATIONS. WE COULD NOT DETECT ANY PRODUCT FAULTS OR MECHANICAL MISUSES. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A RADIAL HEAD FRACTURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT ON (B)(6) 2012, THE RELEASE OPENING ON A SYNEX WITH SMALL END PLATE DID NOT WORK. DURING INSTRUCTION, THE FEELING OF THE CLOSING OF RELEASE OPENING WAS STRANGE COMPARED TO THE OTHER DEVICES, ALTERNATIVE IMPLANT DEVICES WERE ARRANGED ADDITIONALLY. SO, THE RELEASE OPENING IN QUESTION WAS NOT USED FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175294 SYNEX W/SMALL END-PL H28-40 -5° TAN GREE MQP SYNTHES GMBH 7755766

    Patients

    Seq Age Sex Outcome Treatment
    1