BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT FOR PEN DRIVE

    MDR report key: 3231264 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04449
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES DZI, ERL, HBE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES ANSPACH. THE CUSTOMER'S COMPLAINT THAT THE DEVICE SPINS WAS CONFIRMED VIA A FUNCTIONAL ASSESSMENT WHICH DETERMINED THAT THE CONE SLEEVE SPINS. IT WAS REPORTED THAT THIS IS DUE TO NORMAL WEAR OVER TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ¿THE LOT NUMBER 1336093 BELONGS TO THE PART 50152382, WHICH IS THE HOUSING OF THE ARTICLE 05.001.039. THE MANUFACTURING DOCUMENTS OF THIS HOUSING WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DHR REVIEW IS INDETERMINATE AS THE PROVIDED PART/LOT COMBINATION IS INCORRECT BECAUSE THE HISTORY OF THE MACHINE IS UNKNOWN AT SYNTHES (B)(4) AS DOCUMENTED IN THE LOCAL SERVICE CENTRE.¿

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, THE SAGITTAL SAW ATTACHMENT SPINS CONTINUALLY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331512 SAGITTAL SAW ATTACHMENT FOR PEN DRIVE HWE SYNTHES USA 1336093

    Patients

    Seq Age Sex Outcome Treatment
    1