BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LED RING F/HANDLE F/PIEZOELECTRIC SYSTEM

    MDR report key: 4347997 · Received December 19, 2014

    Report

    Report Number
    2520274-2014-01059
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    JDX
    PMA / PMN Number
    K100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES. 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. (B)(4). ADD'L DEVICE INFO: UNDETERMINED; LOT NUMBER IS UNKNOWN. THE DEVICE IS AN INSTRUMENT, NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATIONS HAVE BEEN CONDUCTED. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED FOR THE DEVICE. THE MANUFACTURING EVALUATION WAS PERFORMED BY THE SUPPLIER WHO REVEALED NO ANOMALY EXISTED WITH THE LED RING AND THE PART CONFORMED TO SPECIFICATIONS. THE SUPPLIERS MANUFACTURING RECORDS WERE FURTHER REVIEWED BY DEPUY SYNTHES AND CONCLUDED: BASED ON THE EVALUATION PERFORMED, THE UNKNOWN CAUSE, AND THE UNKNOWN LOT NUMBER, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    THE CONSULTANT REPORTED AN EVENT OCCURRED ON (B)(6) 2011 WHILE SURGEON WAS USING THE PIEZOELECTRIC CUTTING DEVICE DURING AN UNKNOWN SURGERY. THE DEVICE WAS NOT PROPERLY CALIBRATED (SETTING WAS TOO LOW) FOR BONE CUTTING. THE SURGEON EXPERIENCED DIFFICULTY IN USING DEVICE. AFTER THE PROCEDURE, THE SURGEON TOOK THE DEVICE APART AND DISCOVERED A SCORCH MARK NEAR THE POSITIVE PIN ON THE LED ELEMENT. NO REPORT OF TIME DELAY OR HARM TO PATIENT. A NEW LED ELEMENT WAS INSTALLED ON THE DEVICE. THIS REPORTED EVENT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839101 LED RING F/HANDLE F/PIEZOELECTRIC SYSTEM INSTR, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT JDX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1