BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LWPROF WRIST FIXATOR W/SCHANZSCR Ø4/2.5+

    MDR report key: 2989152 · Received March 5, 2013

    Report

    Report Number
    1719045-2013-00454
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 7, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K090658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURE DATES: 12/1/10, 12/7/10, 11/16/10, AND 11/16/10. AN ADDITIONAL EVALUATION WAS CONDUCTED BY (B)(4) AND THE REPORT STATES: THE LOW PROFILE WRIST FIXATOR WAS FORWARDED TO THE RESPONSIBLE PRODUCT UNIT FOR EVALUATION. IT WAS DETERMINED THE CLAMP WAS NOT WORKING PROPERLY BECAUSE THE RETAINING SCREW WAS NOT HOLDING. THROUGH SIMPLE PRESSING DURING TIGHTENING IT WAS POSSIBLE TO FIX THE SCREW AS IT SHOULD. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF WRONG ASSEMBLING/HANDLING. FURTHER, A MANUFACTURING EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: SYNTHES (USA) (B)(4) MANUFACTURED THE ARTICULATING WRIST FIXATOR (THE CLAMP) AND THE SCREWS WERE MADE IN SYNTHES (USA) (B)(4). DUE TO AN UNKNOWN CAUSE THE CLAMP WOULD NOT HOLD THE SCREWS IN PLACE. THE MATERIAL AND DIAMETER OF THE SCREW WERE FOUND TO CONFORM AS WELL AS THE MATERIAL AND HOLE-SIZE IN THE CLAMP. UPON TESTING, ALL OF THE CLAMPS HOLD THE SCREWS AND EVERYTHING SEEMS TO WORK CORRECTLY. FINALLY, A REVIEW OF THE DEVICE HISTORY RECORD(S) (DHR) SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 IN WHICH THE SURGEON WAS USING A SYNTHES LOW-PROFILE WRIST FIXATOR KIT, THE CLAMP WOULD NOT WORK PROPERLY. IT COULD NOT FIX THE SCHANZ SCREW AS IT SHOULD HAVE. SURGEON HAD TO USE A NEW KIT, AND NO FURTHER COMPLICATION WAS REPORTED. NO INJURY TO THE PATIENT REPORTED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93290 LWPROF WRIST FIXATOR W/SCHANZSCR Ø4/2.5+ KTT SYNTHES MONUMENT 6551460

    Patients

    Seq Age Sex Outcome Treatment
    1