BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIKED WASHER 13.5MM/6.5MM

    MDR report key: 3012340 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10538
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTN
    PMA / PMN Number
    K011583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4). 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. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A BICEP TENODESIS PROCEDURE, SURGEON WAS INSERTING THE SPIKED WASHER THROUGH THE LONG BICEPS TENDON INTO THE HUMERUS, WHEN THREE OF THE SPIKES BROKE OFF HALFWAY UP THE SPIKE AND THEN THE SPIKED WASHER CRACKED. THE 4.5MM CORTEX SCREW PULLED THROUGH THE WASHER. SURGEON USED A REGULAR WASHER WITH THE SAME SCREW TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115370 SPIKED WASHER 13.5MM/6.5MM HTN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1