BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3200960 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04016
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART WAS RECEIVED. INVESTIGATION IS ONGOING. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.THE COMPLAINT OF THE DEVICE FALLING APART COULD NOT BE CONFIRMED. THE DEVICE WAS EVALUATED AND THE COMPLAINT WASN''T SUBSTANTIATED. HOWEVER IT WAS OBSERVED THAT A BLADE CAN''T BE REMOVED FROM THE OSCILLATING HEAD. THIS IS MOST LIKELY DUE TO USAGE WEAR OVER TIME.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CONSULTANT REPORTS THAT DURING A SHOULDER RECONSTRUCTION PROCEDURE, THE SAGITTAL SAW ATTACHMENT FELL APART. IT IS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO THE PATIENT. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303106 SAGITTAL SAW ATTACHMENT HWE SYNTHES (USA) 9604

    Patients

    Seq Age Sex Outcome Treatment
    1