BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPTS

    MDR report key: 4368532 · Received December 22, 2014

    Report

    Report Number
    2520274-2014-05185
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RETURNED AND EVALUATIONS ARE COMPLETED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A MANUFACTURER EVALUATION WAS CONDUCTED; IT REPORTED THE DEVICE AS RECEIVED CONDITION: ONE TIP BROKEN AT THE HINGE AND CONCLUDED: DEVICE MEET SPECIFICATIONS AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    CONSULTANT REPORTED AN EVENT OCCURRED ON (B)(6) 2011 WHILE THE SURGEON WAS PERFORMING A CUNEIFORM FUSION PROCEDURE; THE PLATE SNAPPED AND BROKE. THE SURGEON SELECTED ANOTHER INSTRUMENT AND COMPLETED THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO PIECES TO RETRIEVE. NO HARM TO THE PATIENT AND NO TIME TO THE PROCEDURE WAS EXTENDED. THIS REPORT IS 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845381 COMPRESSION FORCEPTS INSTRUMENT COMPRESSION HWN SYNTHES (USA) T950731

    Patients

    Seq Age Sex Outcome Treatment
    1