BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 16/11 F/PFNA BLADE

    MDR report key: 3171613 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02775
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 3, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. OUR INVESTIGATION HAS SHOWN THAT THE HOLDING MECHANISM OF THE PROTECTION SLEEVE FELL APART. THE HOLDING PIN FELL OUT WHICH RESULTED IN THE HOLDING MECHANISM FALLING APART. THE EXACT CAUSE OF THE REPORTED PROBLEM IS UNDETERMINED. THE SEPARATION OF THE PIN IS INDICATIVE OF HEAT APPLIED DURING CLEANING OR WEAR AND TEAR ON THE SURFACE. A NEWER DESIGN HAS BEEN IMPLEMENTED, THE DEVICE IN QUESTION IS FROM AN OLDER DESIGN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PFNA SURGICAL OPERATION, THE DOCTOR INSERTED THE HELICAL BLADE, AND THEN PRESSED THE BUTTON OF THE PROTECTION SLEEVE TO RELEASE THE INSERTER DRIVER. THE BUTTON CAME OFF OF THE PROTECTION SLEEVE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272457 PROTECT SLEEVE 16/11 F/PFNA BLADE FZX SYNTHES GMBH 2513410

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR