BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM

    MDR report key: 3081825 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11151
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    January 19, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    CONSULTANT REPORTED: PATIENT IMPLANTED WITH NAIL AND SCREWS ON AN UNKNOWN DATE. PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR REVISION SURGERY OF INTER-MEDULLARY NAIL OF TIBIA. SURGEON REMOVED ALL HARDWARE DUE TO NON-UNION OF FRACTURE. SURGEON REVISED PATIENT WITH A LARGER DIAMETER NAIL, TIBIA NAIL PROXIMAL BEND. CONSULTANT ALSO REPORTED, THE REDUCTION CLAMP BROKE DURING THE PROCEDURE, NO HARM TO PATIENT. THIS IS 1 OF 5 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185295 REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM HTD SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1