BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIP DOUBLE SIDED STRYKER 76X12.5X1.00/1.19MM

    MDR report key: 5537664 · Received March 31, 2016

    Report

    Report Number
    0002950261-2016-00004
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 16, 2016
    Report Date
    August 29, 2016
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW NOTED NO SPONTANEOUS ANOMALIES, REQUEST FOR DEVIATIONS, NON-CONFORMANCES OR OTHER ISSUES WITH THE PRODUCTION OF THIS DEVICE. THE REVIEW OF THE MANUFACTURING PROCESS AND THE ENGINEERING DESIGN NOTED NO SYSTEMIC ISSUES WITH THIS DEVICE. THE CUSTOMERS REPORTED EVENT WAS THAT THE SAW BLADE GOT STUCK IN THE BONE DURING USE AND THE BLADE WOULD NOT LOCK IN THE HAND PIECE. AFTER REMOVING THE SAW BLADE FROM THE HAND PIECE USING PLIERS, IT WAS NOTED THAT THE LOCKING TABS WERE MISSING. INSPECTION AT INCOMING CONFIRMS THAT THE MOUNTING TABS WERE MISSING. HISTORICALLY, THE MOST PROBABLE CAUSE FOR THIS EVENT IS THE SAW BLADE BINDING DURING USE. THE USUAL CAUSE FOR BINDING SAW BLADES IS MOVING THE SAW HAND PIECE TOO QUICKLY FOR THE SAW TEETH TO ADEQUATELY CUT THE MATERIAL. THE REPORTED EVENT NOTED THAT THE SAW BLADE GOT STUCK. MOST LIKELY THE PUSHING AND PULLING ON THE HAND PIECE TO FREE THE BOUND SAW BLADE CAUSED THE LOCKING TABS TO TEAR AWAY FROM THE MOUNTING HUB. THIS WOULD CAUSE THE SAW BLADE TO NOT REATTACH AND LOCK. THE GALLING AND SCRATCHES NOTED ON THE SAW BLADE AT INCOMING INSPECTION ARE PROBABLY DUE TO THE PUSHING AND PULLING AS WELL AS THE USE OF THE PLIERS TO REMOVE THE BLADE. THERE ARE NO RECOMMENDED ACTIONS AT THIS TIME; THE SEVERITY AND FREQUENCY DO NOT WARRANT FURTHER ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS CUTTING FOR A "BOX" ON A P.S KNEE. THE SAW BLADE WAS STUCK IN BONE. THE SURGEON NOTICED THAT THE BLADE WOULD NOT LOCK INTO THE STRYKER SYSTEM 7. THE RECIPROCATING SAW BLADE WAS REMOVED WITH PLIERS AND CUT WAS FINISHED WITH A NEW BLADE. UPON INSPECTION OF THE BLADE, IT WAS NOTICED THAT LOCKING TABS WERE MISSING ON SAW BLADE. THE SURGEON TOOK INTEROPERATIVE X-RAYS AND COULD NOT LOCATE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196030 RECIP DOUBLE SIDED STRYKER 76X12.5X1.00/1.19MM RECIPROCATING SAW BLADE STRYKER® GFA SYNVASIVE TECHNOLOGY, INC. N/A 55114

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR