BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    MDR report key: 3183803 · Received June 23, 2013

    Report

    Report Number
    8030965-2013-04000
    Event Type
    Malfunction
    Date Received
    June 23, 2013
    Date of Event
    March 14, 2012
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K042365
    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE VISUAL INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE TIP IS DEFORMED DUE TO MECHANICAL OVERLOAD SITUATION DURING INSERTION. MICROSCOPIC EVALUATION SHOWS THAT THE PITCHES OF THE SCREW THREAD ARE PARTIALLY FLATTENED, IT APPEARS THAT THE TIP GOT DAMAGED DURING INSERTION INTO VERY HARD MATERIAL POSSIBLY BONE. NO PRODUCT FAULT COULD BE DETECTED. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT REASON CAUSING THE REPORTED PROBLEM. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6).

    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 510K #: K042365. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    TIP OF THE SCREW WAS DULL, THE DOCTOR INSERTED THE SELF-DRILLING SCREW INTO THE SKULL ON (B)(6) 2012, BUT THIS SCREW COULD NOT BE INSERTED INTO THE SKULL. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284742 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C HWC SYNTHES GMBH 2618184

    Patients

    Seq Age Sex Outcome Treatment
    1