BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3062517 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-01706
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED AND IS ENTERING THE COMPLAINT SYSTEM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING AN ORIF PROXIMAL FEMUR ON (B)(6) 2013, THE SURGEON HAD DIFFICULTY ALIGNING DISTAL SCREW FOR INSERTION AND REPORTED THAT THE AIMING ASSEMBLY, SPECIFICALLY THE AIMING ARM AND HANDLE WERE SUSPECT. THE SURGEON WAS ABLE TO INSERT THE DISTAL SCREW BY MANIPULATING AND SLIGHTLY BENDING THE DRILL SLEEVE. THE PROCEDURE PROLONGED 5 MINUTES AND COMPLETED TO THE SATISFACTION OF THE SURGEON. THIS IS 1 OF 2 REPORT FOR THE SAME EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164351 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES GMBH 3312047

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR