BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER-CRUCIF-CANN Ø3

    MDR report key: 3130951 · Received May 24, 2013

    Report

    Report Number
    2530088-2013-00822
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 10, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE ADDITIONAL EVALUATION REVEALED THAT THE CRUCIFORM TIP OF THE SCREWDRIVER IS BROKEN OFF AS COMPLAINED. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED IN DECEMBER 2007 AND THAT IT CONFORMS TO THE SPECIFICATIONS. WE THEREFORE CONCLUDE THAT THE CAUSE OF THE FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCES CAUSED THIS BREAKAGE. THE SCREWDRIVER WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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. DEVICE MANUFACTURE DATE WAS 03/12/2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER BROKE OFF JUST ABOVE THE CONNECTION TO THE SCREWDRIVER SHAFT. THE BREAKAGE OCCURRED WHILE TRYING TO REMOVE THE SCREW WITH A CANULATED SCREWDRIVER INSTEAD OF A SOLID ONE. THERE WAS NO HARM TO THE PATIENT, THE BROKEN PARTS WERE REMOVED, AND PIECES WERE DISCARDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231734 SCRDRIVER-CRUCIF-CANN Ø3 HXX SYNTHES BRANDYWINE 5640226

    Patients

    Seq Age Sex Outcome Treatment
    1