BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS INSERTION HANDLE

    MDR report key: 3081842 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11186
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 19, 2011
    Report Date
    November 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL INSPECTION PERFORMED AS PART OF THE PRODUCT EVALUATION REVEALED THE TANG WAS BROKEN OFF THE RETURNED PART. A DESIGN CHANGE WAS MADE TO ADDRESS THIS ISSUE. THIS HANDLE WAS MADE PRIOR TO THE DESIGN CHANGE AND PRIOR COMPLAINTS WERE DETERMINED TO BE VALID FOR THIS CONDITION SO THIS IS VALID AND THE REQUIRED CORRECTIVE ACTION HAS BEEN IMPLEMENTED. A CAPA RISK ASSESSMENT WAS COMPLETED FOR THE IDENTIFIED NON-CONFORMANCE. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED. THIS DESIGN CHANGE REDUCED THE PROBABILITY THAT THE TANG WOULD BREAK OFF. COMPLAINT EVALUATIONS WILL CONTINUE TO BE MONITORED FOR THIS PART TO CONFIRM THAT THE OCCURRENCE RATE HAS BEEN REDUCED AS ANTICIPATED.

    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

    PERCUTANEOUS INSERTION HANDLE AND THE TOOTH TO GUIDE THE NAIL BROKE OFF. PIECE WAS RETRIEVED AND THE NAIL WAS INSERTED COMPLETING THE PROCEDURE. ACCOUNT DISCARDED THE BROKEN TOOTH FOR THE INSTRUMENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184158 PERCUTANEOUS INSERTION HANDLE LXH SYNTHES GMBH 1436102

    Patients

    Seq Age Sex Outcome Treatment
    1