BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 32MM

    MDR report key: 3022902 · Received March 27, 2013

    Report

    Report Number
    1719045-2013-10445
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 15, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. ADD'L PRO CODE: DZL. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE SAMPLE WAS NOT 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. ACTUAL EVENT DATE IS UNKNOWN AS IT IS UNKNOWN WHEN THE PATIENTS PAIN STARTED. PREVIOUSLY INCORRECTLY REPORTED.

    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 3/9/12.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MAUDE REPORT # (B)(4), A PATIENT WAS IMPLANTED WITH THREE SCREWS IN THE LEFT FOOT ON (B)(6) 2011 FOR TREATMENT OF LISFRANC INJURY. THE PATIENT EXPERIENCED PAIN AND A BROKEN SCREW WAS IDENTIFIED ON (B)(6) 2012. SURGEON REMOVED ALL THREE SCREWS. ONE OF THE THREE SCREWS WAS FRACTURED DURING REMOVAL. THE TIPS OF BOTH SCREWS WERE LEFT IN THE PATIENT. FRACTURE UNION WAS OPTIMAL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126383 2.7MM CORTEX SCREW SELF-TAPPING 32MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR