BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 3022248 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-01080
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION HAS SHOWN THE COUPLING PRONGS OF THE FLEXIBLE SHAFT ARE BADLY DAMAGED. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2013, A SYNREAM HEAD BURST INTO PIECES DURING REAMING OF A TIBIAL CANAL. THIS LEFT SHARDS OF THE REAMER HEAD STUCK IN THE CANAL. THE SURGEON WAS UNABLE TO CONTINUE REAMING AND INSERT A TIBIAL NAIL, SO HE USED AN EXTERNAL FIXATOR TO MANAGE THE FRACTURE INSTEAD. IT IS REPORTED THAT THIS INCIDENT ADDED CONSIDERABLE TIME TO THE CASE, ABOUT ONE TO ONE AND A HALF HOURS. IT IS ALSO REPORTED THAT IT WAS UNCERTAIN IF THE GUIDE WIRE THAT WAS BEING USED WAS A SYNTHES GUIDE WIRE. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124665 SYNREAM FLEXSHAFT HTO SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention