BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE

    MDR report key: 3062315 · Received April 16, 2013

    Report

    Report Number
    3003787298-2013-10074
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    August 10, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 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. ADDITIONAL NARRATIVE: (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE STERILIZATION OF A HOLDING SLEEVE, THE FLANGE PART OF THE INSTRUMENT IS TOO FAR APART AND WON'T FIT TOGETHER. THE INSTRUMENT CANNOT BE USED FOR SURGERY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162399 HOLDING SLEEVE HXX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1