BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2926039 · Received January 23, 2013

    Report

    Report Number
    8030965-2013-00217
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. WE HAVE SENT THE COMPLAINED SCREW TO OUR MATERIAL SCIENCE AND TESTING DEPARTMENT FOR INVESTIGATION. THE MATERIAL MET SPECIFICATIONS. AN EXAMINATION VIA SEM WAS COMPLETED: THE PRESENT SCREW BROKE ACCORDING TO A DUCTILE FORCED FRACTURE DURING INSERTION BY APPLYING A HIGH TORSIONAL LOAD. A REASON FOR AN INTRA-OPERATIVE FAILURE FOR THE MATRIX NEURO SCREW COULD BE INSERTION OF THE SCREW IN AN EXCEPTIONAL HARD BONE WITHOUT PRE-DRILLING. THE PERFORMED INVESTIGATION COULD NOT DETECT ANY MATERIAL FAULTS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE FOR A PATIENT WITH A BRAIN TUMOR: TWO SCREWS BROKE UPON INSERTION. ONE SCREW, THE TIP WAS BROKEN, THE SECOND SCREW THE SCREW HEAD WAS CHIPPED OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32467 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C MATNEU SCREW JEY SYNTHES GMBH 2761242

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR