BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DRILL BIT STRYKER J-LATCH/12MM STOP/82MM

    MDR report key: 3070394 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10838
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # PE00385 REVEALED THAT THE PRODUCT CONFORMED TO ALL MANUFACTURING REQUIREMENTS AND SHOWED NO COMPLAINT RELATED ISSUES. THE DEVICE WAS BROKEN AT THE JUNCTURE BETWEEN THE DRILL BIT AND THE STOP. THERE DID NOT APPEAR TO BE ANY OTHER DAMAGE TO THE DEVICE. THE MANUFACTURING EVALUATION SHOWED THAT THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING AT SYNTHES INCOMING INSPECTION. THE COMPLAINT PRODUCT MET DIMENSIONAL SPECIFICATIONS AND THE MATERIAL AND HARDNESS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION CONDUCTED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE 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 DURING A STERNAL FRACTURE OPEN REDUCTION INTERNAL FIXATION, THE DRILL BIT BROKE WHILE THE SURGEON WAS DRILLING DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED. THE SURGEON USED A NEW DRILL BIT AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM OR HARM TO THE PATIENT. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172242 1.5MM DRILL BIT STRYKER J-LATCH/12MM STOP/82MM HTW SYNTHES MONUMENT PE00385

    Patients

    Seq Age Sex Outcome Treatment
    1