BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT 3.5 T15 SELF-HOLD L245

    MDR report key: 3131754 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01491
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    November 22, 2010
    Report Date
    January 28, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE SCREWDRIVER TIP IS INDEED BROKEN APART. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. WHILE WE ASSUME THAT FAR TOO MUCH MECHANICAL FORCE MAY HAVE CAUSED THE BREAKAGE OF THE TIP, UNFORTUNATELY, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. PLEASE NOTE THAT THIS IS THE FIRST COMPLAINT RECORD RECEIVED ASSOCIATED WITH THIS DEVICE AND AFTER REVIEWING THE MANUFACTURING DOCUMENTS, WE DETERMINE, THAT THIS IS AN ISOLATED CASE. NO PRODUCT FAULT COULD BE DETECTED. DEVICE HISTORY REVIEW RESULTS CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE THAT FAR TOO MUCH MECHANICAL FORCE MAY HAVE CAUSED THE BREAKAGE OF THE TIP, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER SNAPPED OFF WHILE THE SURGEON WAS ATTEMPTING TO UNSCREW THE GRUB SCREW ON THE CONNECTOR. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236486 SCRDRIVER SHAFT 3.5 T15 SELF-HOLD L245 HXX SYNTHES MONUMENT 4691448

    Patients

    Seq Age Sex Outcome Treatment
    1