BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS PLATE-STANDARD BARREL 4 HOLES/78MM

    MDR report key: 3010164 · Received March 19, 2013

    Report

    Report Number
    3003506883-2013-00104
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE EVENT RELEVANT MEASURES WERE CHECKED AND FOUND TO MEET THE SPECIFICATIONS REFERRING TO DRAWING SE_024610 VERS. A.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING A HIP FRACTURE PROCEDURE, IT WAS REPORTED THE SURGEON TRIED TO PLACE A 135 DEGREES DHS PLATE-STANDARD BARREL 4 HOLES OVER THE INSERTION GUIDE AND IT WOULD NOT FEED OVER. THE SURGEON TRIED SEVERAL TIME AND FINALLY USED ANOTHER PLATE WHICH WENT OVER VERY EASILY. REPORTEDLY THERE WAS NO PATIENT HARM DURING THE SURGERY; HOWEVER, THE PROCEDURE WAS EXTENDED BEYOND 15 MINUTES.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114041 135 DEG DHS PLATE-STANDARD BARREL 4 HOLES/78MM KTT SYNTHES ELMIRA 6849712

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention