BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINECTOMY PUNCH UP-BITING 40 DEG-SIZE 1/177MM

    MDR report key: 2862084 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01474
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE DHR SHOWS THAT THE HARDNESS MET SPECIFICATION AT TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND THE REPORT INDICATES THE TIP OF THE LOWER JAW - ABOUT 3MM LONG - OF THE INSTRUMENT HAS BROKEN. THE REST OF THE INSTRUMENT IS FUNCTIONAL. THE MATERIAL OF THE INSTRUMENT IS STAINLESS STEEL WITH HIGH STRENGTH ATTRIBUTES. THE PRODUCTION YEAR FOR THIS INSTRUMENT IS 2005. SINCE THE INSTRUMENT HAS BEEN IN THE FIELD FOR MORE THAN 6 YEARS, THE LIKELY CAUSE OF FAILURE IS DUE TO WEAR AND TEAR. BUT THERE IS NO SPECIFIC CAUSE THAT COULD BE POINTED OUT WITH THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING AN ACDF AT C5-C6, C6-C7 WHEN THE TIP OF THE KERRISON FROM THE LAMINECTOMY PUNCH BROKE OFF INTO THE PATIENTS WOUND AT C6-C7. THE SURGEON WAS ABLE TO RETRIEVE THE PART AND CONFIRMED BY X-RAY THAT ALL BROKEN PARTS WERE RETRIEVED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMINECTOMY PUNCH UP-BITING 40 DEG-SIZE 1/177MM LAMINECTOMY PUNCH UP-BITING KWP SYNTHES GMBH A70A48

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR