BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AO/ASIF-QC F/COMPACT AIR DRIVE+POWER DRI

    MDR report key: 4038999 · Received August 26, 2014

    Report

    Report Number
    8030965-2014-10465
    Event Type
    Injury
    Date Received
    August 26, 2014
    Report Date
    August 8, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION A NEW PART NUMBER FOR THE PRODUCT INVOLVED IN THE EVENT WAS PROVIDED. THEREFORE, THE BRAND NAME, COMMON DEVICE NAME, AND DEVICE PRODUCT CODE HAVE UPDATED TO REFLECT THIS INFORMATION. ALSO, THE PMA/510K NUMBER AND THE DATE OF MANUFACTURE HAVE BEEN UPDATED. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING A SURGICAL PROCEDURE FOR THE TREATMENT OF A FEMORAL FRACTURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE FELL APART. THE SURGEON STATED THAT DUE TO THE COMPLEXITY OF THE SURGERY, IT WAS NOT POSSIBLE TO COLLECT ALL PARTS OF THE DEVICE ¿IN THE SAME MOMENT.¿ ACCORDING TO THE REPORT, AFTER THE REPAIR CENTER TECHNICIAN CHECKED THE DEVICE, IT WAS OBSERVED THAT TWO SMALL SCREWS WERE MISSING. THE REPORTER STATED THAT X-RAY WAS USED TO CHECK THAT ONLY THE SCREWS RELATED TO THE SURGERY WERE IN POSITION. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515869 AO/ASIF-QC F/COMPACT AIR DRIVE+POWER DRI INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention