BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

    MDR report key: 4789894 · Received May 21, 2015

    Report

    Report Number
    0001032347-2015-00221
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    April 23, 2015
    Report Date
    October 14, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. FIELDS WERE UPDATED BASED ON THE DEVICE BEING RECEIVED FOR EVALUATION. SUPPLEMENTAL REPORT ONE OF SIX FOR THE SAME EVENT, SEE ALSO 1032347-2015-00216-1, 1032347-2015-00217-1, 1032347-2015-00218-1, 1032347-2015-00219-1 AND 1032347-2015-00220-1.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. FILE SIX OF SIX FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE PLATE (PART NUMBER 73-2634) REPORTED IN THIS FILE WAS NOT RETURNED FOR EVALUATION.FIFTEEN (15) STERNALOCK BLU LOCKING SCREWS (POTENTIAL PART # 73-2414, 73-2418, 73-2420, AND 73-2720, LOT #S UNKNOWN) AND ONE PLATE 8 HOLE X (PART# 73-2623, LOT# UNKNOWN) WERE RECEIVED; NOT ALL SCREWS AND PLATES PER THE PRODUCT LIST WERE RETURNED. A VISUAL EXAMINATION OF THE RETURNED PLATE DETERMINED THAT THE PLATE WAS FRACTURED IN HALF AND HAD SIGNIFICANT DAMAGE IN THE FORM OF DEFORMATION ALONG THE THREADED HOLES AND SURFACE, CUT EDGE, AND SCRATCHES AND DISCOLORATION ALONG THE SURFACE. THE INFORMATION PROVIDED STATED THE SURGEON HAD TO REMOVE THE SCREWS AND PLATES, CUTTING A FEW OF THE PLATES AND AFFIXING THEM ON THE BORDER OF THE STERNUM TO ASSIST WITH PREVENTING THE WIRES FROM PULLING THROUGH. VISUAL INSPECTION OF THE RETURNED SCREWS DETERMINED THAT ALL SCREWS THREADS CLOSE TO THE HEAD HAD DEFORMATION; SOME SCREW HEADS EXPERIENCED MORE DEFORMATION AND DISCOLORATIONS THAN OTHERS WHICH MAY BE INDICATIVE OF SURGICAL TECHNIQUE (E.G. ANGLE OF INSERTION OR DEGREE OF ENGAGEMENT INTO THE PLATE.) A REVIEW OF THE SUPPLIED X-RAYS CONFIRMED SCREWS HAD DISENGAGED FROM THE IMPLANT AND WERE NO LONGER FIXATED TO THE PLATE OR BONE. BASED ON THE CONDITION OF THE RETURNED IMPLANTS NO FUNCTIONAL EXAMINATION WAS PERFORMED. THE SCREWS EXHIBIT SIGNS OF USAGE IN THE FORM OF DEFORMATION AND THE SUPPLIED X-RAYS CONFIRM THE IMPLANTS HAVE DISENGAGED AND WERE NO LONGER FIXATED AS INTENDED. BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINANT AND EXAMINATION OF THE RETURNED IMPLANTS, THE MOST LIKELY ROOT CAUSE FOR THE DAMAGE CANNOT BE DETERMINED. VARIOUS FACTORS, SUCH AS THE PATIENT BEING IDENTIFIED AS CLINICALLY OBESE, SURGEON TECHNIQUE, AND/OR PATIENT BONE QUALITY MAY HAVE PLAYED A ROLE IN THE FAILURE OF THE DEVICE.SUPPLEMENTAL REPORT SIX OF SIX FOR THE SAME EVENT, REFERENCE 1032347-2015-00216-2, 1032347-2015-00217-2, 1032347-2015-00218-2, 1032347-2015-00219-2 AND1032347-2015-00220-2.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED AFTER HEART SURGERY THE SURGEON USED WIRES TO CLOSE THE STERNUM. THE WIRES PULLED THROUGH THE STERNUM RESULTING IN QUITE A FEW TRANSVERSE FRACTURES DUE TO WIRE PULL THROUGH. THE SURGEON PERFORMED A REVISION USING STERNALOCK BLU IMPLANTS. A COUPLE WEEKS LATER IT WAS IDENTIFIED SOME SCREWS BACKED OUT OF THE PLATE. THE SURGEON PERFORMED A REVISION SURGERY AND REMOVED THE SCREWS AND PLATES AND CUT A FEW OF THE PLATES AND AFFIX THEM ON THE BORDER OF THE STERNUM TO ASSIST WITH PREVENTING THE WIRES FROM PULLING THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332469 BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R