BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT-SLEEVE 16/11 F/PFNA BLADE

    MDR report key: 2883748 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01657
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THE BLADE IS COMPLETELY STUCK IN THE PROTECTION SLEEVE AS COMPLAINED. THEREFORE IT IS IMPOSSIBLE TO SEPARATE THE PARTS AND THE RELEVANT DIMENSIONS CAN NOT BE CHECKED ANYMORE. HOWEVER, THE VISUAL INSPECTION SHOWS THAT THE BLADE IS STUCK IN AN OFFSET ANGLE OF ABOUT 30° FROM THE ALIGNMENT MARKING AT THE TOP OF THE PROTECTION SLEEVE. THIS IS A CLEAR INDICATION THAT THE BLADE WAS NOT PROPERLY ALIGNED WITH THE SLEEVE DURING THE INSERTION AND THAT THIS MISALIGNMENT FINALLY CAUSED THE JAMMING OF BOTH DEVICES. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. NO CONCLUSION CAN BE DRAWN AS THE DEVICE IS ENTERING THE INVESTIGATION PROCESS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) WHERE A BLADE BECAME BLOCKED IN THE PROTECTION SLEEVE. REPORTEDLY THE BLADE WAS INSERTED IN THE WRONG DIRECTION AND CONTINUED FORCE HAD BEEN APPLIED IN AN ATTEMPT TO ADVANCE THE BLADE THROUGH THE SLEEVE AND INTO THE BONE. THE PROCEDURE HAD TO BE ALTERED SLIGHTLY TO ALLOW FOR BLADE INSERTION. REPORTEDLY A FREEHAND INSERTION OF A NEW BLADE WAS PERFORMED TO COMPLETE THE PROCEDURE. THIS IS THE FIRST OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECT-SLEEVE 16/11 F/PFNA BLADE PROTECT-SLEEVE 16/11 F/PFNA BLADE KTT SYNTHES GMBH 2104905

    Patients

    Seq Age Sex Outcome Treatment
    1