BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    MDR report key: 3070066 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10439
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 29, 2012
    Report Date
    June 29, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE FIRST THREAD IN THE SCREW HEAD IS DAMAGED AND THE BLUE ANODIZE HAS BEEN COMPLETELY SCRAPED OFF. THERE ARE SOME SCRATCHES IN THE STARDRIVE RECESS FROM ENGAGEMENT OF A SCREWDRIVER TIP. THE RETURNED PART FUNCTIONS AS INTENDED AND THIS IS INVALID IN RELATION TO THE SCREW.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLF AT L4-S1, MINIMALLY INVASIVE, THE SCRUB TECH WAS TIGHTENING SCREW ONTO DRIVER AT BACK TABLE, BUT SCREW WOULD NOT ENGAGE PROPERLY. IT IS NOT KNOWN IF SCREW BECAME CROSSTHREADDED OR IF A PIECE OF THE DRIVER TIP BROKE OFF INTO IT. SURGEON USED ANOTHER SCREW AND DRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171721 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6914107

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR