BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNSCR Ø7.3 SELF-DRILL L85/16 TAN GOLD

    MDR report key: 3191547 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03766
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    October 6, 2011
    Report Date
    October 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K962011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. CONCOMITANT MEDICAL PRODUCTS: REMOVAL OF BRAND NAME FROM THIS SECTION. IT IS NOT A CONCOMITANT DEVICE. PLACEHOLDER.

    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 EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE SURFACES OF THE CROSS-SECTIONS WERE SHOWN TO BE HOMOGENOUS; NO ANOMALIES OF MATERIALS STRUCTURE WERE FOUND. THE MEASURABLE DIMENSIONS OF THE SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH (B)(4) SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TO TREAT A FEMORAL NECK FRACTURE ON A (B)(6) FEMALE PATIENT, THE TIP OF A 7.3 MM CANNULATED SCREW FRAGMENTED FROM THE MAIN BODY. ALL FRAGMENTS OF THE SCREW TIP WERE RECOVERED FROM THE PATIENT THROUGH X-RAY LOCATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290087 CANNSCR Ø7.3 SELF-DRILL L85/16 TAN GOLD HWC SYNTHES GMBH 2564226

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR CANNSCR Ø7.3 SELF-DRILL L85/16 TAN GOLD