BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 2903510 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00211
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED IN PIECES. THE WOODEN HANDLE FRACTURED AT ITS LOCATION WHERE IT'S SECURED TO THE SHAFT WITH A DOWEL PIN. TWO SMALL HANDLE FRAGMENTS AND ONE LARGE HANDLE PIECE WITH END CAP STILL RETAINED. THE SHAFT ALSO FRACTURED AT THE LOCATION WHERE IT IS SECURED TO THE HANDLE BY A DOWEL PIN. THE DOWEL PIN REMAINS CAPTURED IN THE LARGE HANDLE FRAGMENT. THE HANDLE AND SHAFT ON THE RETURNED DEVICE HAVE BOTH FRACTURED AT THE LOCATION WHERE THEY ARE SECURED TO EACH OTHER BY A DOWEL PIN. THE SHAFT SURFACE AT THE FRACTURE SITE IS BENT WHICH INDICATES A SIDE LOAD WAS ENCOUNTERED CAUSING THE BEND AND ULTIMATELY THE BREAKAGE OF BOTH THE SHAFT AND HANDLE. THE HANDLE COMPONENT IS MADE FROM PHENOLIC LE GRADE LINEN MATERIAL WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE HANDLES FOR NUMEROUS DEVICES. THE SHAFT COMPONENT IS MADE FROM 304SS WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE SHAFTS FOR NUMEROUS DEVICES. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE IS OVER 15 YEARS OLD AND BASED ON AGE AND WEAR, IT HAS OUTLIVED ITS USEFUL LIFE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DURING A VOLAR COLUMN DISTAL RADIUS PROCEDURE ON (B)(6) 2012 A HANDLE OF A SCREWDRIVER FELL APART. ALL PIECES OF THE HANDLE WERE RETRIEVED THE SURGEON HAD ANOTHER SCREWDRIVER AVAILABLE TO USE, AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11449 HANDLE WITH QUICK COUPLING, SMALL HANDLE WITH QUICK COUPLING, SMALL LXH SYNTHES GMBH 2104

    Patients

    Seq Age Sex Outcome Treatment
    1