BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 2970241 · Received February 20, 2013

    Report

    Report Number
    2530088-2013-10141
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT DEVELOPMENT EVALUATION VISUAL RESULTS REVEALED THE POLYAXIAL SCREW ASSEMBLY WAS RETURNED WITH THE BODY AND COLLET ASSEMBLED AND THE SCREW SEPARATED FROM THE ASSEMBLY. THE COLLET COMPONENT OF THE POLYAXIAL BODY ASSEMBLY SHOWS MINIMAL SIGNS OF WEAR FROM CONTACT WITH THE OUTSIDE OF THE SCREW HEAD FROM THE ASSEMBLED STATE. THERE IS NO VISUALLY OBVIOUS DAMAGE TO THE POLYAXIAL BODY. THE THREADS IN THE SCREW HEAD ARE NEARLY SHEARED OFF FROM ENGAGEMENT WITH A HOLDING SLEEVE. THERE ARE TWO SETS OF MARKS / GOUGES 180 DEGREES APART ON THE BONE SCREW THREADS NEAR THE HEAD OF THE SCREW. THE POLYAXIAL SCREW THREADS WERE DAMAGED BY THE HOLDING SLEEVE THREAD BECOMING LOOSE DURING SCREW INSERTION THEN MANIPULATING THE HOLDING SLEEVE OFF-AXIS. THE MARKS ON THE BONE SCREW THREADS ARE THE RESULT OF MISUSE AND NOT DESIGN. THE POLYAXIAL SCREW DESIGN IS ACCEPTABLE. THE CONDITION APPEARS TO BE THE RESULT OF THE HOLDING SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE AND ALSO TO MISUSE, THEREFORE THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    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 LUMBAR FUSION PROCEDURE, THE PEDICLE PROBE (388.536) BENT FROM LATERAL FORCE APPLIED BY SURGEON WHILE HE WAS CANNULATING PEDICLE. SURGEON USED THE PROBE TO COMPLETE THE PROCEDURE. THE BENT PROBE WAS NOTED AFTER THE PROCEDURE WAS COMPLETED. AFTER SCREW INSERTION, WHILE SURGEON WAS TIGHTENING DOWN THE SCREW, HE NOTICED THAT THE TIP OF THE SCREWDRIVER (03.632.002, 03.632.072) WAS NICKED/GOUGED. DURING SCREW INSERTION, A PIECE OF THREAD CAME OFF OF THE HOLDING SLEEVE (03.632.036). IN ADDITION, THE HEAD OF THE MATRIX POLYAXIAL SCREW (04.632.745) BROKE OFF DURING SCREW INSERTION. NOTHING BROKE INTO WOUND. ALL BROKEN PIECES WERE RETRIEVED, NO HARM TO PATIENT. NOTHING BROKE INTO THE WOUND, ALL BROKEN PIECES WERE RETRIEVED AND THE SURGEON COMPLETED THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73926 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6642817

    Patients

    Seq Age Sex Outcome Treatment
    1