BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3072666 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10437
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. PRODUCT DEVELOPMENT EVALUATION REPORTS THAT THE PART WAS RECEIVED WITH THE NEEDLE BROKEN OFF WHERE IT THREADS INTO THE SLIDER. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL UNIFORMITY. ONLY THE SLIDER WAS RETURNED SO THE LOT NUMBER COULD NOT BE CONFIRMED SINCE IT IS ETCHED ON THE BODY. THE BODY, NEEDLE, AND PROTECTION SLEEVE WERE NOT RETURNED FOR INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PREVIOUSLY NOTED, THE THICKNESS OF THE PROBE IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE OF 1.5 MM, AND THE LENGTH IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS UP TO 40 MM. THE MATERIAL OF THE PROBE IS EXTRA HARD, WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT OF THIS TYPE. TO FURTHER REDUCE THE RISK OF ACCIDENTAL BREAKAGE, A PROTECTIVE SLEEVE IS INCLUDED WITH THE DEVICE THAT THREADS ONTO THE NOSE PIECE AND PROTECTS THE NEEDLE WHEN NOT IN USE. IT CANNOT BE DETERMINED IF IT WAS USED AS RECOMMENDED BUT THE LOCATION OF THE BREAK ON THE NEEDLE SHAFT IS CONTAINED WITHIN THE NOSE PIECE WHEN THE DEVICE IS ASSEMBLED. THEREFORE, THE BENDING AND BREAKAGE MUST HAVE HAPPENED WHEN THE DEVICE WAS DISASSEMBLED. IT IS CONCLUDED THAT THE DESIGN IS ADEQUATE FOR THE INTENDED USAGE. THEREFORE, A DESIGN ISSUE WAS NOT FOUND AND THIS COMPLAINT IS CONSIDERED INVALID.

    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.A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A SMALL PIECE ON THE MODULAR FOOT DEPTH GAUGE, THAT HOOKS ON TO BONE, BROKE. IT IS UNKNOWN AS TO HOW OR WHEN DEVICE BROKE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175033 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 6318318

    Patients

    Seq Age Sex Outcome Treatment
    1