BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET ADAPTER T2 SCN

    MDR report key: 4607426 · Received March 17, 2015

    Report

    Report Number
    0009610622-2015-00112
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 23, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THIS INVESTIGATION REVEALED THE TARGET ADAPTER T2 SCN TO BE AS PRIMARY PRODUCT. THE NAIL HOLDING SCREW T2 SCN AND THE NAIL ADAPTER T2 SCN ARE REGARDED AS ASSOCIATED PRODUCTS. DISCREPANCIES IN MANUFACTURING WERE NOT FOUND. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS IT HAD BEEN IN USE FOR A LONGER TIME (MORE THAN 10 YEARS) WE PRE-SUPPOSE THAT THE TARGET ADAPTER T2 SCN HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. PRE-OPERATIVE-CHECK PERFORMED REVEALED THE TARGET ADAPTER T2 SCN, NAIL HOLDING SCREW T2 SCN AND THE NAIL ADAPTER T2 SCN RETURNED BEING FULLY FUNCTIONAL WITH SAMPLE NAIL, SAMPLE TISSUE PROTECTION SLEEVE, SAMPLE DRILL SLEEVE, SAMPLE DRILL AND SAMPLE NAIL. THE SUBJECT OF THE REPORTED EVENT COULD NOT BE REPRODUCED. IT CAN ONLY BE ASSUMED THAT THE FIXATION SCREW WAS NOT TIGHTENED AS REQUIRED OR THAT THE FIXATION SCREW WAS LOOSENED UNINTENTIONALLY DURING THE PROCEDURE. IN BOTH CASES THE TARGETING ARM WILL NOT STAY IN SECURED POSITION FOR DRILLING. THE REPORTED EVENT WAS NOT CAUSED BY ANY DEFICIENCY IN THE DEVICES. PRE-SUPPOSING THAT TARGETING ACCURACY FOR DRILLING WAS CONFIRMED BY PRE-OPERATIVE CHECK IT WAS CONCLUDED THAT THE EVENT(S) WERE MAINLY BASED IN THE INTRA-OPERATIVE PROCEDURE. ALTHOUGH A REAL ROOT CAUSE COULD NOT BE DETERMINED THE ALLEGED EVENT IS MOST LIKELY CAUSED DUE TO A SUBOPTIMAL INTRA-OPERATIVE PROCEDURE. IT IS IN THE RESPONSIBILITY OF THE SURGEON THAT HE JUST DID NOT PUT THAT SCREW IN AND FINISHED THE PROCEDURE.

    Description of Event or Problem · 1

    SURGEON STATED THAT DEVICE DID NOT LOCK PROPERLY AND A SCREW MISSED THE NAIL. THE SURGERY WAS FINISHED WITHOUT THE SCREW.

    Description of Event or Problem · 1

    SURGEON STATED THAT DEVICE DID NOT LOCK PROPERLY AND A SCREW MISSED THE NAIL. THE SURGERY WAS FINISHED WITHOUT THE SCREW. NEW INFORMATION RECEIVED 2/24/2015 "THE RESOLUTION WAS THE SURGEON DID NOT PUT THAT SCREW IN AND FINISHED THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181096 TARGET ADAPTER T2 SCN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KP213356

    Patients

    Seq Age Sex Outcome Treatment
    1 Other