BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3272668 · Received August 8, 2013

    Report

    Report Number
    8030965-2013-04503
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE REPORTERS COMPLAINT THAT THIS DEVICE CAME APART WHEN THE UNIT WAS ACTIVATED WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE COUPLING IS DAMAGED. THIS IS DUE TO NORMAL WEAR OVER TIME. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE LOT # (1429) PROVIDED IN THE INITIAL MEDWATCH IS A SUPPLIER LOT #. THE SYNTHES LOT # IS; 5043580.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PROXIMAL HUMERUS PROCEDURE, WHILE THE DEVICE WAS BEING ASSEMBLED IT CAME APART WHEN THE SURGEON PULLED THE TRIGGER. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY THREE MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING THE SPARE DEVICE WITH NO FURTHER PROBLEM AND NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372641 SAGITTAL SAW ATTACHMENT HWE SYNTHES GMBH 5568977

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR