BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3192943 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03582
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 16, 2012
    Report Date
    March 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON SCREW INSERTION THE HEAD OF THE SCREW SHEARED OFF AT THE SHAFT, THE HEAD ALSO BROKE OFF. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT. THE DOCTOR DID NOT PREDRILL BUT THE REST OF THE SCREWS USED, INSERTED FINE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294457 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1