BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARP HOOK

    MDR report key: 3062297 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10864
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT CLAVICLE, THE SURGEON USED THE SHARP HOOK TO CAPTURE A BONE FRAGMENT. THE HOOKED TIP OF THE INSTRUMENT BROKE OFF INTO THE WOUND, ALL PIECES WERE RETRIEVED. THE SURGEON USED ANOTHER SHARP HOOK TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162285 SHARP HOOK LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1