BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

    MDR report key: 3160430 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-03045
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 4, 2011
    Report Date
    April 22, 2011
    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 THE RECORD INDICATES THE PARTS WERE MANUFACTURED IN CONFORMANCE WITH SYNTHES SPECIFICATIONS. THE PRODUCT INVESTIGATION AND VISUAL INSPECTION DID NOT SHOW ANY DISCREPANCIES FROM THE SPECIFICATION. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE SCREW HEAD BROKE DURING FINAL TIGHTENING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260376 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C JEY SYNTHES GMBH 2690760

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR