BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTERSINK FOR 4.5MM CORTEX

    MDR report key: 3015171 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-10383
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (B)(4) 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 SUPPLEMENT MDR. MANUFACTURING EVALUATION REPORTS THE SAMPLE WAS RECEIVED AND VISUAL INSPECTION NOTED THE CENTERING PIN ON THE TIP WAS BROKEN OFF AND MISSING. THE BROKEN SURFACE IS HOMOGENOUS INDICATING MATERIAL CONFORMITY SAME AS THE MANUFACTURING RECORDS. THE BREAKAGE IS POSSIBLY INDICATIVE OF MECHANICAL OVERLOAD DURING USAGE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE COUNTERSINK BROKE OFF. INSTRUMENT WAS NOT USED FOR THIS CASE, BUT WHEN THE INSTRUMENT SET WAS TAKEN TO DECONTAMINATION, THE (B)(4) TECHNICIAN FOUND THAT THE TIP OF THE COUNTERSINK WAS BROKEN OFF AND MISSING. IT IS UNKNOWN WHEN THE PIECE WAS BROKEN AND WHETHER IT HAPPENED DURING SOME OTHER SURGERY, AS THE SPD TECH DID NOT NOTICE IT AT THE TIME OF PREVIOUS REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84665 COUNTERSINK FOR 4.5MM CORTEX HWW SYNTHES GMBH 2168157

    Patients

    Seq Age Sex Outcome Treatment
    1