BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3220876 · Received July 11, 2013

    Report

    Report Number
    2530088-2013-01030
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE WAS EVALUATED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT DEVELOPMENT EVALUATED THE PRODUCT AND THE EVENT: THE BROKEN COMPONENT ON THE DEPTH GAUGE NEEDS TO BE SMALL IN DIAMETER IN ORDER FOR THE MEASUREMENT NEEDLE TO FIT THROUGH A HOLE DRILLED IN THE BONE. INCREASING THE DIAMETER OF THE NEEDLE WOULD NOT ALLOW THE NEEDLE TO FIT THROUGH THE DRILLED HOLE. THE SMALL DIAMETER NEEDLE IS INHERENTLY SUSCEPTIBLE TO BREAKAGE BECAUSE OF THIS NECESSITY OF SMALL DIAMETER GEOMETRY. (B)(4). THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE. THERE IS NO INDICATION TO THE CAUSE OF THE COMPLAINT. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEPTH GAUGE BROKE DURING A PROCEDURE. THE INSTRUMENT WAS RECOVERED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320246 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 5026649

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR