BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3478299 · Received November 20, 2013

    Report

    Report Number
    8030965-2013-05298
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Report Date
    October 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. DHR NOT AVAILABLE AS DEVICE IS OLDER THAN 13 YEARS. THE DOCUMENTS FOR INSTRUMENTS HAVE TO BE STORED FOR 10 YEARS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. SYNTHES LOT# IS 4091549.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ADDITIONAL EVALUATION REPORTS THAT THE REPORTER DID NOT ALLEGE OR IDENTIFY ANY DEFICIENCY; IT WAS OBSERVED DURING PRE REPAIR ASSESSMENT TEST THAT THE UNIT IS RUNNING HOT, ROUGH AND HAS BLADE FLOPPING . EVIDENCE SUGGESTS THIS IS DUE TO USAGE WEAR OVER TIME.

    Description of Event or Problem · 1

    FACILITY RETURNED THE SAGITTAL SAW ATTACHMENT FOR ROUTINE SERVICE. DURING PRE-TEST IT WAS NOTED THE DEVICE RUNS ROUGH, THE BLADE FLOPS AND GETS HOT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604197 SAGITTAL SAW ATTACHMENT HWE SYNTHES GMBH 00571

    Patients

    Seq Age Sex Outcome Treatment
    1