BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11143

    MDR report key: 3081830 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11143
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES (USA
    Product Code
    HWC
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 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. ORIGINAL AWARENESS DATE IS 03/21/2012.

    Description of Event or Problem · 1

    DURING FINAL TIGHTENING OF THE LAST SCREW WITH THE TORQUE ATTACHMENT, THE SCREW MIGRATED THROUGH THE TI 2-COLUMN PLATE AND INTO BONE, DISASSOCIATING THE SCREW FROM THE PLATE. SURGEON DID NOT BACK OUT THE PLATE OR SCREWS. SURGEON LEFT THE CONSTRUCT IN PLACE. HE FELT IT WOULD CAUSE MORE PROBLEMS RECTIFYING THE PROBLEM. THE TORQUE ATTACHMENT PROVIDED 1.2 NM OF TORQUE WHICH MAY HAVE BEEN TOO MUCH TORQUE. SURGEON COULD HAVE POSSIBLY OVER-TORQUED THE SCREW WITH THE TORQUE ATTACHMENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4). SCREW LOT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184154 HWC SYNTHES (USA

    Patients

    Seq Age Sex Outcome Treatment
    1