BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REC DBL SIDED STRYKER 76 X 13 X 1.19MM

    MDR report key: 5537493 · Received March 31, 2016

    Report

    Report Number
    0002950261-2016-00003
    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
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    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 IS MANUFACTURED IN THE ZIMMER BIOMET (B)(4). THE INFORMATION FOR THIS RESPONSE WAS PROVIDED BY THE QUALITY DEPARTMENT AT THE EL DORADO HILLS FACILITY. THE 12076119SRL IS THE CATALOGUE NUMBER FOR PURCHASING THE RECIPROCATING DOUBLE SIDED STRYKER® RECIP STRYKER HUB 76X13X1.00/1.19MM. THE REPORTED TRACE LOT NUMBER WAS NOT REPORTED AND IS UNKNOWN. NO DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THE CUSTOMERS REPORTED EVENT WAS THAT THE SAW BLADE LOCKING TABS BROKE OFF WHEN PERFORMING A ¿BOX CUT¿. VISUAL INSPECTION NOTED THE LOCK TABS WERE MISSING ON THE HUB AND UNDER MAGNIFICATION AREAS OF SIGNIFICANT STRESS MARKS AND GALLING WERE FOUND ON THE MOUNTING HUB. CONSULTING WITH THE PRODUCT DEVELOPMENT ENGINEERS AT SYNVASIVE, IT SEEMS THE MOST LIKELY CAUSE FOR THIS REPORTED EVENT IS USING AN INCORRECT SAW BLADE FOR THIS SPECIFIC CUT. DURING THE ¿BOX CUT¿ THE SAW BLADE IS "PLUNGED¿ TIP FIRST LIKE A KNIFE. IDEALLY A SAW BLADE WITH TEETH NEAR THE TIP WOULD BE USED TO ASSURE CUTTING A PATH FOR THE SAW BLADE TO FOLLOW. WITHOUT THIS SAWING ACTION SIGNIFICANT SHEAR STRESS WOULD BE PLACED ON THE SAW BLADE LOCKING TABS. A CLOSURE LETTER SHALL BE FORWARDED SO THE AREA SALES REPRESENTATIVE CAN REVIEW THE FINDINGS OF THIS COMPLAINT WITH THE USER.

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO MFR CONTACT INFORMATION FOR CORRECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS MAKING BOX CUT ON A PERSONA PS KNEE USING THE RECIPROCATING SAW AND THE FINS THAT HELD THE SAW BLADE IN THE SAW BROKE APART MAKING THE BLADE UNUSABLE. THERE WAS NO HARM, INJURY OR ADVERSE EVENT TO PATIENT/OPERATOR, NOR WAS THE LIFE/HEALTH OF PATIENT AT RISK. THE INFORMATION REGARDING THE SECOND BLADE WAS SUBMITTED IN A SEPARATE MDR (2950261-2016-00007) AND WAS REMOVED FROM THIS SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS MAKING BOX CUT ON A PERSONA PS KNEE USING THE RECIPROCATING SAW AND THE FINS THAT HELD THE SAW BLADE IN THE SAW BROKE APART MAKING THE BLADE UNUSABLE. A SECOND BLADE WAS OPENED AND THE SURGEON FINISHED THE CUT. AFTER THE CASE, IT WAS NOTICED BY THE SCRUB TECH THAT ANOTHER FIN SHEARED AWAY FROM THE SECOND BLADE. THERE WAS NO HARM, INJURY OR ADVERSE EVENT TO PATIENT/OPERATOR, NOR WAS THE LIFE/HEALTH OF PATIENT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196165 REC DBL SIDED STRYKER 76 X 13 X 1.19MM RECIPROCATING SAW BLADE STRYKER® RECIP GFA SYNVASIVE TECHNOLOGY, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1