BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER FOR MIDFACE PLATES

    MDR report key: 3133189 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02371
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE ORIGINALLY RECEIVED ON (B)(4) 2013. THE DEVICE WAS RETURNED BECAUSE IT HAD A BROKEN TIP. THE DEVICE WAS RECEIVED AT SERVICE AND REPAIR WHO CONDUCTED A VISUAL EVALUATION AND DETERMINED THE DEVICE COULD NOT BE REPAIRED. THE DEVICE WAS DISCARDED. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT. THERE ARE NO KNOWN NCRS ASSOCIATED WITH THIS ITEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. THE ITEM WAS RECEIVED WITH A BROKEN TIP. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SERVICE AND REPAIR DEPARTMENT THAT THE TIP OF THE PLATE CUTTER FOR MIDFACE PLATES WAS BROKEN. NO SURGICAL INFORMATION IS AVAILABLE. THIS COMPLAINT IS FOR A WARRANTY REPLACEMENT ONLY. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THE REPORTED INSTANCE WAS AN ANTICIPATED SERVICE OR WARRANTY REPLACEMENT ISSUE. NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236759 PLATE CUTTER FOR MIDFACE PLATES HTZ SYNTHES GMBH 3444663

    Patients

    Seq Age Sex Outcome Treatment
    1