BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL SCREWDRIVER SHAFT - II

    MDR report key: 5436146 · Received February 15, 2016

    Report

    Report Number
    3003853072-2016-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    December 12, 2015
    Report Date
    January 18, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE ATTEMPTS FOR ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS RECEIVED AND THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. WITHOUT THE RETURN OF THE DEVICE, NO EVALUATION OR EXPERTISE ON PRODUCT CAN BE PERFORMED. THE REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATIONS OR DEVIATIONS IN PROCEDURES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON LIMITED AND INCOMPLETE INFORMATION, NO ADDITIONAL INVESTIGATION COULD BE PERFORMED, AND THE ROOT CAUSE OF ISSUE CAN NOT BE DETERMINED. (B)(4). PMA/510(K) NUMBER WAS CORRECTED FROM EXEMPT TO K111301. CONCLUSIONS -UNABLE TO CONFIRM COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THE FINAL SCREWDRIVER SHAFT WAS BROKEN DURING DEFORMITY OPERATION OF THE SPINE. IT IS REPORTED THE INSTRUMENT WAS USED IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THERE WAS NO IMPACT ON PATIENT, AND NO DELAY OF OPERATION AS A SECOND INSTRUMENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94493 FINAL SCREWDRIVER SHAFT - II SCREWDRIVER NKB ZIMMER SPINE N/A A2102903A

    Patients

    Seq Age Sex Outcome Treatment
    1