BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM

    MDR report key: 3020857 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10428
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ONE (BROKEN) SCREW WAS RECEIVED WITH THIS COMPLAINT. APPROX. 10.3MM OF THE THREADED PORTION HAS BEEN BROKEN OFF FROM THE END OF THE SCREW. THE SCREW IS, OTHERWISE, IN GOOD CONDITION WITH LIGHT SIGNS OF WEAR CONSISTENT WITH USE. THE DIMENSIONS THAT COULD BE CHECKED ARE WITHIN TOLERANCE. BECAUSE OF THE TYPE AND EXTENT OF DAMAGE INCURRED, AND BECAUSE NO LOT NUMBER WAS PROVIDED, THIS COMPLAINT IS JUDGED TO BE 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

    IT WAS REPORTED THAT DURING AN ORIF RIGHT DISTAL TIBIA/FIBULA FRACTURE, THE 4.0MM CANCELLOUS BONE SCREW BROKE AT THE SHAFT/THREAD JUNCTION DURING INSERTION. THE SHAFT OF THE SCREW WAS RETRIEVED AND THE THREADS WERE LEFT IN THE PATIENT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    AS REPORTED, THE PROCEDURE TOOK PLACE DUE TO A NONUNION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124457 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR