BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

    MDR report key: 2990132 · Received March 5, 2013

    Report

    Report Number
    2530088-2013-00239
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED DEPTH GAUGE WAS RECEIVED IN 2 PIECES, THE OUTER SLEEVE IS SEPARATE FORM THE DEPTH GAUGE BODY-NEEDLE. DURING THIS EVALUATION, THE DEPTH GAUGE OUTER SLEEVE SLIDES ON THE DEPTH GAUGE BODY WITH RESISTANCE. NO LOOSE CONDITION COULD BE REPLICATED. THE RETURNED DEVICE WAS MANUFACTURED IN APRIL 2008 AND IS APPROXIMATELY 5 YEARS OLD. THE COMPLAINT CONDITION IS DEPTH GAUGE ON THE OUTER SLEEVE IS A LITTLE TOO LOOSE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DEPTH GAUGE OUTER SLEEVE SLIDES ON THE DEPTH GAUGE BODY WITH SLIGHT RESISTANCE. (B)(4). THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ANOMALIES WERE FOUND. PRODUCT DEVELOPMENT EVALUATION NOT YET COMPLETE. THIS DEVICE WAS USED FOR TREATMENT. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING ORIF SURGERY OF THE PELVIS ON (B)(6) 2013, THE SURGEON NOTED THAT THE DEPTH GAUGE ON THE OUTER SLEEVE WAS A LITTLE TOO LOOSE. THE SURGEON WAS HAVING A HARD TIME MEASURING THE DEPTH OF THE SCREWS. THE SURGERY WAS PROLONGED ABOUT 10 TO 15 MINUTES DUE TO THE EXTRA TIME IT TOOK TO MEASURE THE SCREWS. SURGERY WENT FINE, NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94351 DEPTH GAUGE FOR 3.5MM CORTEX SCREWS DEPTH GAUGE FOR 3.5MM CORTEX SCREWS HTJ SYNTHES BRANDYWINE 5759413

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR