BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW BLADE STRYKER® RECIP

    MDR report key: 6376514 · Received March 3, 2017

    Report

    Report Number
    0002950261-2017-00001
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 30, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RECORDED UNDER (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE SURGICAL BLADE REPORTED ON THE ORIGINAL COMPLAINT TO DEPUY LISTED PART NUMBER 229910002 FROM LOT NUMBER KD6AC4000. THIS PRODUCT NUMBER AND LOT NUMBER IS THE IDENTIFICATION USED BY DEPUY TO MARKET THIS BLADE. THIS BLADE IS MANUFACTURED AT THE ZIMMER SURGICAL EL DORADO HILLS FACILITY. THE MANUFACTURING PART NUMBER FOR THIS SURGICAL BLADE WITHIN ZIMMER SYNVASIVE IS 11-2819-01. THE ZIMMER PRODUCTION LOT NUMBER FOR THE BLADE ON THIS REPORTED EVENT IS WO# 62035. PRODUCT NUMBER 13076119SR1 IS THE ZIMMER SYNVASIVE CATALOGUE NUMBER FOR PURCHASING THE RECIPROCATING DOUBLE SIDED STRYKER® RECIP STRYKER HUB 76 X 13 X 1.00/1.19 MM. THE DEVICE HISTORY REVIEW (DHR) WAS PERFORMED. THE LOT WAS MANUFACTURED AND RELEASED INTO INVENTORY ON 29 MAR, 2016. THERE WERE NO NON-CONFORMANCES (ND¿S) ENGINEERING CHANGES NOTICES (CN¿S), REQUEST FOR DEVIATIONS (RFD¿S) OR ANY OTHER REPORTED ANOMALIES DURING MANUFACTURE. ALL TESTING AND INSPECTION REQUIREMENTS WERE MET. WITHOUT THE RETURNED PRODUCT FOR EVALUATION THE REPORTED EVENT CANNOT BE DEFINITIVELY CONFIRMED. WITHOUT CONFIRMATION OF THE REPORTED EVENT AND WITH JUST THE AVAILABLE INFORMATION A ROOT CAUSE DETERMINATION CANNOT BE MADE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE WAS FRACTURED OR BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158103 RECIPROCATING SAW BLADE STRYKER® RECIP BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A KD6AC4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR