BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 3193348 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03155
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 16, 2012
    Report Date
    January 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION OF THE COMPLAINED SCREWS SHOWS THAT BOTH TIPS ARE INDEED BADLY DEFORMED DUE TO MECHANICAL OVERLOADING. MICROSCOPIC EVALUATION SHOWS THAT THE PITCHES OF THE SCREW THREADS ARE FLATTENED. IT APPEARS THAT THE TIPS GOT DAMAGED DURING INSERTION INTO VERY HARD MATERIAL. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON CAUSING THE REPORTED PROBLEM. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WOULD NOT INSERT INTO SKULL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292033 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C HWC SYNTHES GMBH 2790503

    Patients

    Seq Age Sex Outcome Treatment
    1