BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANNULATED SCREW SHORT THREAD/50MM

    MDR report key: 3082848 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10970
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. MANUFACTURING EVALUATION NOTED THERE WAS EXTENSIVE THREAD DAMAGE AT THE TIP END OF THE SCREW. THERE WAS A SMALL PORTION OF THE THREADS NOT DAMAGED PAST THE SECTION OF PEELED THREADS. THERE ARE VISIBLE SCRATCHES AROUND THE ENTIRE CIRCUMFERENCE OF THE SHAFT JUST BELOW THE HEAD. THERE IS A WASHER ON THE PART; PART NUMBER UNKNOWN. VISUAL EXAMINATION IS CONSISTENT WITH PRODUCT COMPLAINT. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR WERE CHECKED AT THE PORTION OF THREAD WITHOUT DAMAGE AND NO ISSUES WERE FOUND. HOWEVER THESE FEATURES COULD NOT BE CHECKED AT TIP END DUE TO DAMAGE. SINCE THERE WERE NO ISSUES FOUND ON THE SECTION OF THREADS THAT COULD BE CHECKED AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING AN ORIF SUPRA CONDLYAR EVULSION FRACTURE ELBOW PROCEDURE, WHILE INSERTING THE SCREW, THE SCREW UNRAVELED AT THE TIP. THE SURGEON USED ANOTHER SCREW AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. ALL PIECES WERE REMOVED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185618 4.0MM CANNULATED SCREW SHORT THREAD/50MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR