BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/46MM

    MDR report key: 3032297 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-11048
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE THREADS ON THE DAMAGED SCREW ARE FLATTENED THEREFORE COULD NOT BE CHECKED. ALSO ON THE SAME SCREW, THE TIP IS DAMAGED THEREFORE THE FLUTES COULD NOT BE CHECKED. SINCE NO ISSUES WERE FOUND DURING DIMENSIONAL ANALYSIS ON FEATURES THAT COULD BE INSPECTED AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.THE MANUFACTURING EVALUATION STATES THAT ONE OF THE RETURNED SCREWS IS IN GOOD CONDITION AND THERE IS NO OBVIOUS DAMAGE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT OR DIAGNOSIS.ADDITIONAL NARRATIVE: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 REPORT IS FOR QUANTITY: 2 OF 4.5MM CANNULATED SCREW PARTIALLY THREADED/ 46/MM.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A SYNDESMOSIS INJURY UNDERWENT AN ORIF ON AN UNKNOWN DATE. INCLUDED IN THE SURGEON'S PLAN WAS A REMOVAL OF THE TWO SCREWS ON (B)(6) 2012. DURING THE REMOVAL OF THE SCREWS, ONE OF THE TIPS OF THE SCREWS BROKE OFF AND IT IS UNKNOWN IF THE BROKEN TIP WAS RETRIEVED OR NOT. THE TWO EXPLANTED SCREWS, EXCLUDING THE BROKEN TIP, ARE AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    WHEN REMOVING THE SCREW, PIECES OF METAL RETAINED.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135595 4.5MM CANNULATED SCREW PARTIALLY THREADED/46MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR