BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN

    MDR report key: 3130947 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02352
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. THE ADDITIONAL EVALUATION REVEALED THAT THE CAUSE OF THE BREAKAGE WAS DUE TO OVERSTRESS OF THE INSTRUMENT. THE SURFACE OF THE BREAK IS HOMOGENOUS, WHAT SHOWS MATERIAL CONFORMITY. WE GUESS THAT BOTH OF THE PLATES WERE NOT CONNECTED WHEN SEATING THE INSTRUMENT. AS A RESULT, THE FORCES MEASURED WERE ONE SIDED TO THE TIPS OF THE ATTACHMENT PINS WHAT CAUSED THE BREAK. NO PRODUCTION FAULTS COULD BE DETERMINED. IT IS CONCLUDE THAT THIS COMPLAINT IS INVALID. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS COMPLAINT WAS DETERMINED TO BE INVALID.

    Description of Event or Problem · 1

    TIPS ARE BROKEN OFF. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232185 INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN HWB SYNTHES GMBH 2198282

    Patients

    Seq Age Sex Outcome Treatment
    1