BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3033491 · Received April 3, 2013

    Report

    Report Number
    2530088-2013-10356
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012. NEW INFORMATION WAS RECEIVED (B)(4) 2013.

    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT DEVELOPMENT EVALUATION STATED THAT THE NEEDLE WAS RECEIVED BROKEN OFF WHERE IT THREADS INTO THE SLIDER. THE THREAD ON THE PIECE PROTRUDING FROM THE SLIDER IS DEFORMED AND BENT TO ONE AND THE TIP WITH THE HOOK IS BENT BACKWARDS. ALL COMPONENTS OF THE DEVICE ARE PRESENT EXCEPT THE PROTECTION SLEEVE WHICH WAS NOT RETURNED. THE THICKNESS OF THE PROBE IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE, AND THE LENGTH IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS UP TO 40 MM. THE MATERIAL OF THE PROBE IS EXTRA HARD 316SS, WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT OF THIS TYPE. THE RETURNED DEVICE WAS MANUFACTURED IN FEBRUARY 2010 AND ITS 2 YEARS OLD. TO FURTHER REDUCE THE RISK OF ACCIDENTAL BREAKAGE, A PROTECTIVE SLEEVE IS INCLUDED WITH THE DEVICE THAT THREADS ONTO THE SLIDER AND PROTECTS THE NEEDLE WHEN NOT IN USE. THE SLEEVE WAS NOT RETURNED WITH THIS INSTRUMENT AND IT CANNOT BE DETERMINED IF IT WAS USED AS RECOMMENDED. BASED ON THE DEFORMATION NOTED ON THE THREAD ABOVE THE FRACTURE FACE, THE NEEDLE WAS BENT SIGNIFICANTLY TO THE SIDE WHICH RESULTED IN THE NOTED BREAKAGE. 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 USE. THEREFORE, THIS EVALUATION FOUND THAT THERE IS NOTHING TO INDICATE A DESIGN ISSUE AND THIS COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PHALANX OF THE HAND PROCEDURE, THE TIP OF THE DEPTH GAUGE SNAPPED OFF WHILE THE SURGEON WAS MEASURING. THE BROKEN FRAGMENT WAS RETRIEVED. SURGEON USED ANOTHER DEPTH GAUGE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135740 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 6194123

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR