BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3163975 · Received June 12, 2013

    Report

    Report Number
    2530088-2013-00913
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND A MRR (#(B)(4)) WAS FOUND ON P/N 319.006.01 LOT #4195417 FOR T1 GAUGE TOO TIGHT AND D1 GAUGE GOES TOO FAR INTO ONE END ON SUPPLIER PARTS. THE NONCONFORMING PARTS WERE RE-INSPECTED FOR BOTH T1 AND D1 AND THE D1 PARTS PASSED BUT THE T1 PARTS FAILED. THE 8 NONCONFORMING PARTS FOR T1 WERE SCRAPPED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE THE PROTECTION SLEEVE IS NOT A FUNCTIONAL PART OF THE DEVICE AND IS REMOVED PRIOR TO USE. THE DEVICE HISTORY RECORDS #4181057 FOR P/N ES0003.19 AND #4184818 FOR P/N ES0010.02 WERE NOT REVIEWED BECAUSE THEY WERE NOT ABLE TO BE FOUND IN DOCUSPHERE. THE JDE WAS CHECKED AND BOTH ARE VALID IN JDE FOR THEIR RESPECTIVE PART NUMBERS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THREE DEPTH GAUGES FOR 2.0MM AND 2.4MM SCREWS (PART#319.006) WERE RETURNED FOR EVALUATION. ONE RETURNED DEPTH GAUGE (LOT#4070014) WAS MANUFACTURED IN FEBRUARY 2000 AND IS OVER 13 YEARS OLD. ONE RETURNED DEPTH GAUGE (LOT#4239292) WAS MANUFACTURED IN MARCH 2001 AND IS OVER 12 YEARS OLD. ONE RETURNED DEPTH GAUGE (LOT#3958363) WAS MANUFACTURED IN JULY 1999 AND IS APPROXIMATELY 14 YEARS OLD. NO DAMAGE EXISTS TO TWO OF THE THREE RETURNED DEPTH GAUGES. THE NEEDLE HAS SHEARED OFF AT ITS BASE ON THE OTHER RETURNED DEPTH GAUGE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. BOTH DEVICES FUNCTIONED AS INTENDED. SPECIFICALLY, THE SLEEVE COMPONENT SLIDES ON THE DEPTH GAUGE BODY WITH SLIGHT FRICTION WHICH ALLOWS THE SLEEVE TO STAY IN POSITION AT THE PRECISE MEASURED LOCATION ON THE ETCHED SCALE ON THE BODY. THE NEEDLE BROKE AT THE INTERFACE WITH THE DEPTH GAUGE BODY. THE SPECIFICATION FOR THE THICKNESS OF THE NEEDLE (1.25 MM) IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE OF Ø1.5 MM, AND THE LENGTH (80 MM) IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS UP TO 40 MM. THE MATERIAL OF THE NEEDLE PROBE COMPONENT (PART#319.006.03) IS EXTRA HARD 316SS, WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. THE RISK ASSOCIATED WITH AN INSTRUMENT BREAKING OR BENDING EITHER DUE TO MATERIAL OR GEOMETRY IS ADEQUATELY ASSESSED IN THE RISK ANALYSIS FOR THE COMPACT HAND/MODULAR HAND SYSTEM. TO FURTHER REDUCE THE RISK OF ACCIDENTAL DAMAGE OR BREAKAGE, A PROTECTIVE SLEEVE IS INCLUDED WITH THE DEVICE THAT THREADS ONTO THE NOSE PIECE AND PROTECTS THE NEEDLE WHEN NOT IN USE. THE PROTECTION SLEEVE WAS NOT RETURNED WITH TWO OF THE THREE DEPTH GAUGES INCLUDING THE ONE DEPTH GAUGE WHERE THE NEEDLE BROKE OFF. THEREFORE, THE DAMAGE TO THE NEEDLE CAN BE RELATED TO NOT USING THE PROTECTION SLEEVE WHICH SOLE PURPOSE IS TO PROTECT THE NEEDLE FROM BREAKING OFF. ALL THREE OF THE RETURNED DEVICES ARE OVER 12 YEARS OLD. THE COMPLAINT CONDITION COULD NOT BE REPLICATED FOR TWO OF THEM, WHILE THE THIRD IS CONFIRMED TO HAVE A BROKEN NEEDLE BUT NO LONGER HAS THE PROTECTION SLEEVE WITH IT WHICH PROTECTS THE NEEDLE FROM BREAKING. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORTEDLY THREE (3) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WERE AVAILABLE FOR A SURGERY ON (B)(6) 2013; HOWEVER, THE INSTRUMENTS DID NOT FUNCTION AS INTENDED. IT WAS REPORTED THE FIRST DEPTH GAUGE (LOT # 4239292) WAS TOO LOOSE. THE SECOND DEPTH GAUGE (LOT #3958363) WOULD NOT SLIDE SMOOTHLY. IN ADDITION THE THIRD DEPTH GAUGE (LOT #4070014) WAS FOUND TO HAVE A BROKEN TIP. THE SURGEON WAS ABLE TO USE THE LOOSE DEPTH GAUGE TO COMPLETE THE PROCEDURE. APPROXIMATELY SIX MINUTES WAS ADDED TO THE PROCEDURE DUE TO THIS EVENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266132 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 4239292

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR