BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3052313 · Received April 11, 2013

    Report

    Report Number
    2530088-2013-10362
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    April 25, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH 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. THE DHR WAS REVIEWED AND A SERVICE RECORD FOR REPAIR OF ONE DEVICE WAS FOUND FOR THE TIP BROKEN. THE ONE DEVICE RETURNED FOR REPAIR WAS SCRAPPED. THE PRODUCT IS CHECKED VISUALLY AND FUNCTIONALLY 100 PERCENT AT MANUFACTURE AND PASSED. THE PRODUCT DEVELOPMENT EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE NEEDLE IS BROKEN OFF WHERE IT THREADS INTO THE SLIDER. THE FRACTURE FACES AT BOTH THE NEEDLE AND THE SLIDER ARE HOMOGENOUS WHICH INDICATES MATERIAL UNIFORMITY. THE TIP WITH THE HOOK IS BENT SLIGHTLY BACKWARDS STARTING APPROXIMATELY 15 MM FROM THE TIP OF THE HOOK. THE DEVICE WAS RECEIVED DISASSEMBLED BUT ALL COMPONENTS ARE PRESENT INCLUDING THE PROTECTION SLEEVE. THE DESIGN EVALUATION REPORT STATED THAT AS NOTED IN PRIOR COMPLAINTS, THE THICKNESS OF THE PROBE (1.25 MM) IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE OF 1.5 MM, AND THE LENGTH (80 MM) 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. NEEDLE BREAKAGE, EITHER AT THE BASE OF THE SLIDER OR THE TIP IS IDENTIFIED IN THE RISK ANALYSIS FOR THE STAINLESS STEEL MODULAR HAND SYSTEM WITH A SEVERITY OF 2 (MARGINAL) AND A PROBABILITY OF 3 (OCCASIONAL). BASED ON THE ANALYSIS DONE FOR NR 200287, THE RATE IS APPROXIMATELY 0.55 PERCENT BASED ON SALES OF DEPTH GAUGES AND NUMBER OF COMPLAINTS. SINCE DEPTH GAUGES ARE USED REGULARLY AND REPEATEDLY, THE ACTUAL COMPLAINT RATE WITH RESPECT TO USE IS SIGNIFICANTLY LOWER. THE RETURNED DEVICE WAS MANUFACTURED IN OCTOBER 1997 AND IS OVER 14 YEARS OLD. 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 USE AND THE OCCURRENCE AND SEVERITY ARE WITHIN THOSE DEFINED BY THE PRODUCT RISK ANALYSIS. THEREFORE, THERE IS NOTHING TO INDICATE A DESIGN ISSUE AND THIS COMPLAINT IS DEEMED 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEPTH GAUGE (319.006) IS BROKEN. IT IS UNKNOWN HOW AND WHEN THE DEVICE WAS BROKEN. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.

    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
    154654 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE A4GL730

    Patients

    Seq Age Sex Outcome Treatment
    1