BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3728052 · Received April 4, 2014

    Report

    Report Number
    2520274-2014-10584
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 3, 2014
    Manufacturer
    SYNTHES (JENNERSVILLE)
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE DEVICE HISTORY REVIEW SHOWED ON RAW MATERIAL P/N 31005 LOT #7122703 FOR CERT DOES NOT STATE CONDITION. THE SUPPLIER PROVIDED THE CORRECTED CERT AND THE MATERIAL WAS ACCEPTED BY THE QUALITY ENGINEER. THERE WERE NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE MANUFACTURING EVALUATION SHOWS, ONE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE IS DISASSEMBLED WITH THE SPRING AND BALL COMPONENTS IN A SEPARATE BAG AND THE NEEDLE IS BROKEN OFF EVEN WITH THE END OF THE SLIDER. THE RELEVANT M1.2X0.25-6G THREAD ON THE NEEDLE COMPONENT IS NOT ABLE TO BE CHECKED DUE TO THE THREADS BROKEN OFF AND REMAIN IN THE SLIDER. THE BROKEN OFF THREADS ARE PINNED IN THE SLIDER AND NOT ABEL TO BE REMOVED WITHOUT DESTROYING THE THREADS AND SLIDER. THE MAJOR DIAMETER OF THE THREAD ON THE NEEDLE WAS ABLE TO BE OBTAINED AND PASSED. THE SIDE HOLE (D3) IN THE SLIDER FAILED BECAUSE THE HOLE IS STAKED AT ASSEMBLY TO RETAIN THE BALL AND SPRING. THE STAKING PROCESS DEFORMS THE HOLE AND THE SIDE HOLE FEATURE DOES NOT ACCEPT THE GAGE PIN THEREFORE THE STAKING PROCESS WAS PERFORMED. THE RELEVANT FEATURES THAT WERE ABLE TO BE CHECKED PASSED. THE PRODUCT EVALUATION SHOWS, A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS (PART# 319.006, LOT # UNKNOWN) WAS RETURNED WITH A COMPLAINT CATEGORY OF ¿BROKE¿ (1 PIECE). THE DEPTH GAUGE IS USED IN SEVERAL TECHNIQUE GUIDES, SUCH AS COMPACT FOREFOOT RECONSTRUCTION SCREW SYSTEM AND COMPACT DISTAL RADIUS SYSTEM TO MEASURE FOR SCREW LENGTH. THE DEPTH GAUGE¿S NEEDLE HAS SHEARED OFF THE RETURNED DEVICE AT THE INTERFACE WITH THE DEPTH GAGE BODY. AS NOTED IN PRIOR COMPLAINTS, 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. ADDITIONALLY, 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 BREAKAGE ON THE NEEDLE SHAFT IS CONTAINED WITHIN THE NOSE PIECE WHEN THE DEVICE IS ASSEMBLED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE USED IN VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VETERINARIAN DURING A PROCEDURE, THE INSTRUMENT BROKE. THE SURGEON STATES THAT THERE ARE TWO PIECES THAT CAME OUT OF THE INSTRUMENT WHEN IT BROKE, A BALL BEARING AND ANOTHER PART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY OR PATIENT HARM. THE PROCEDURE COMPLETED SUCCESSFULLY WITH NO HARM TO ANIMAL. THIS DEVICE WAS USED DURING A VETERINARY CASE AND THERE WAS NO HUMAN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204925 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ SYNTHES (JENNERSVILLE) 7327590

    Patients

    Seq Age Sex Outcome Treatment
    1