BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIC-SCR-MATR 5.5 Ø7 L45 TAN

    MDR report key: 3340435 · Received September 10, 2013

    Report

    Report Number
    2530088-2013-01159
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS CONDUCTED AND IT STATES THAT THE LOT NUMBERS LISTED IN COMPLAINT CONDITION ARE FOR STERILE PARTS, HAD TO GO BACK TO DHR TO FIND PRE-STERILE LOT NUMBERS: 6830332 & 7152957, WITH NO DEFINITIVE WAY TO ESTABLISH WHICH LOT IS ASSOCIATED WITH THIS PRODUCT. THE SCREW WAS RECEIVED WITH THE M6.5X0.75-6H THREAD AND 90 PERCENT OF THE HEAD WAS PEELED. THE SD25 FACE HAS NICKS AND SCRATCHES WITH VISUAL DEFORMATION TO FORM. ALL DESCRIBED NONCONFORMITIES ARE POST-MANUFACTURING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: DURING INSERTION OF A MATRIX SCREW IT WAS NOTICED THAT THE RETAINING SLEEVE WAS NOT ENGAGED IN TO THE HEAD OF THE BONE SCREW. AFTER CLOSER INSPECTION IT WAS FOUND THAT A THREAD FROM THE INNER PART OF THE CLICK-ON BONE SCREW HAD SHEARED AWAY. THUS, THE RETAINING SLEEVE WAS UNABLE TO FULLY ENGAGE WITH THE SCREW. THE SCREW WAS REPLACED. THE PATIENT WAS NOT AFFECTED AND THE PROCEDURE CONTINUED. THE LOT NUMBERS HAVE BEEN REPORTED AS BEING: 8244699 OR 8297271. THE OPERATION WAS PROLONGED ONLY BY 2-3 MINUTES WHILE A NEW SCREW WAS OPENED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453881 PEDIC-SCR-MATR 5.5 Ø7 L45 TAN NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1