BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCL-CABLE W/CRIMP 1.7

    MDR report key: 3083435 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11147
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 14, 2014
    Report Date
    August 24, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 CABLE WAS RECEIVED FOR A MANUFACTURING EVALUATION IN GOOD CONDITION. THERE WAS NO NOTICEABLE DAMAGE. PIONEER SURGICAL TECHNOLOGIES MANUFACTURED THE CABLE WITH CRIMP ASSEMBLY. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND DETERMINED THAT THE DEVICE MET ALL SPECIFICATIONS PRIOR TO SHIPPING. THE DIAMETER OF THE CABLE WAS INSPECTED AT THREE LOCATIONS AND PASSED INSPECTION. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING AND THE INVESTIGATION PERFORMED BY THE SUPPLIER, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION.

    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 THE PATIENT HAD A FEMORAL DIAPHYSEAL FRACTURE. DURING THE PROCEDURE, THE DOCTOR FIXED THE BONE WITH THE CARVED BROAD PLATE AND THE CABLE. WHEN THE CABLE WAS FIXED AND TENSIONED, THE BALL OF THE CABLE PENETRATED THE SLEEVE, SO THE CABLE COULD NOT BE FIXED. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185652 CERCL-CABLE W/CRIMP 1.7 JDQ SYNTHES USA 7933848

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR