BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 CANN LONG

    MDR report key: 3193250 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01702
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 7, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE PRESENT SCREWDRIVER HAS BEEN MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. THE INVESTIGATION CARRIED OUT HAS SHOWN THAT THE FIRST COURSE OF THREAD OF THE HOLDING SLEEVE IS DEFORMED. THE INVESTIGATION WITH REFERENCE TO THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE HOLDING SLEEVE HAS BEEN MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. THE INVESTIGATION CARRIED OUT WITH REFERENCE TO THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE PRESENT SCREWDRIVER HAS BEEN MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. IT IS OBVIOUS THAT 1MM BROKE OUT FROM THE SIDE OF THE T25 DRIVE AND THAT THE TIPS WERE TWISTED. THE FRACTURED SURFACES ARE HOMOGENEOUS WHICH IS IN COMPLIANCE WITH THE CONFORMITY OF THE MATERIAL. BASED ON THESE FINDINGS, WE DO NOT ASSUME A MANUFACTURING ERROR.

    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)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP ON BOTH SCREWDRIVERS WAS CUT OFF, THUS THE HOLDING SLEEVE COULD NOT BE ASSEMBLED PROPERLY. BURRS CAN BE FELT ON THE COURSE OF THREAD, WHEREAS THE SCREW CANNOT BE MOUNTED COMPLETELY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294605 SCRDRIVERSHAFT T25 CANN LONG HXX SYNTHES MONUMENT 6605217

    Patients

    Seq Age Sex Outcome Treatment
    1