BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3031510 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01738
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH 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. A REVIEW OF THE DEVICE HISTORY RECORDS REPORTS THE FOLLOWING: PART/SERIAL NUMBER COMBINATION UNKNOWN AT SYNTHES (B)(4), NO DHR REVIEW POSSIBLE.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE AS IT IS NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. MANUFACTURING EVALUATION REVIEWED, MDR REPORTABILITY STATUS UPDATED PER PMRM AND FS-932. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #2520274-2013-01738.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2013 THE HOUSING OF A SAGITTAL SAW ATTACHMENT BECAME LOOSE. REPORTEDLY THIS DEVICE MALFUNCTION CAUSED AN APPROXIMATELY 5 MINUTE DELAY TO SWITCH OUT WITH A SPARE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    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
    134545 SAGITTAL SAW ATTACHMENT HWE SYNTHES USA 1789

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR