BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE

    MDR report key: 2970254 · Received February 20, 2013

    Report

    Report Number
    1719045-2013-10167
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    December 10, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. LOT NUMBER PROVIDED 121337, CANNOT BE VERIFIED. 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.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). YES. BOTH CRIMPERS WERE RECEIVED AND INSPECTED BY SERVICE AND REPAIRS. EXACT DATE UNKNOWN. YES, NO, OTHER; PER THE SERVICE & REPAIRS DEPARTMENT: BOTH CRIMPERS WERE RECEIVED AND INSPECTED. 1 CRIMPER WAS REPAIRED; 1 CRIMPER WAS UNABLE TO BE REPAIRED AND WAS SCRAPPED AND REPLACED. ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO STERNAL CABLE CRIMP INSTRUMENTS (391.291) WERE MALFUNCTIONING DURING A CASE. BOTH INSTRUMENTS WERE CUTTING THE CABLE BEFORE CRIMPING.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73156 TENSIONER/CRIMPER/CUTTER FOR 1.0MM STERNAL CABLE LXH SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1