BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3192651 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03521
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 13, 2012
    Report Date
    March 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE TIPS WERE DEFORMED. THE SCREW THREADS ARE PARTIALLY FLATTENED. MICROSCOPIC EVALUATION SHOWS THAT THE PITCHES OF THE SCREW THREADS ARE PARTIALLY FLATTENED. IT APPEARS THAT THE TIPS WERE DAMAGED DURING INSERTION INTO VERY HARD MATERIAL BONE. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON CAUSING THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART COULD NOT INSERT INTO BONE. THE DEVICE WAS USED FOR THE OPERATION OF CRANIOTOMY. IT WAS INTENDED TO BE INSERTED BUT EACH OF THE THREE SCREWS WERE NOT INSERTED INTO THE BONE. THE TIPS WERE CHECKED AND THEY WERE FOUND TO BE FLATTENED. IT IS NOT CERTAIN THAT THIS INCIDENT HAPPENED AS AN INITIAL FAILURE OR IF THE TIP WAS WORN OUT DURING THE INSERTION. ANOTHER ONE WAS UNPACKED AND USED FOR THE FIXATION. THE OPERATION ENDED WITHOUT A PROBLEM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294640 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C JEY SYNTHES GMBH 2790480

    Patients

    Seq Age Sex Outcome Treatment
    1