BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 3052175 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-01580
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE RETURNED: DATE UNKNOWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED; THE DEVICE WAS FOUND TO BE FUNCTIONAL DURING TESTING. HOWEVER, IT WAS OBSERVED THAT THE HOUSING AND GAUGE OF THE DEVICE EXHIBITED DAMAGE THAT WAS CONSISTENT WITH IT HAVING BEEN MISHANDLED OR DROPPED. WE RECOMMEND THAT THE USER REVIEW THE HANDLING PROCEDURES IN THEIR USER'S MANUAL IN ORDER TO PREVENT A RECURRENCE.

    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.

    Description of Event or Problem · 1

    IT IS REPORTED ON (B)(6) 2012 DURING A TOTAL KNEE REPLACEMENT SURGERY THE BATTERY REAMER DRILL STOPPED WORKING. REPORTEDLY THE DEVICE WAS INITIAL WORKING AND MALFUNCTIONED DURING THE PROCEDURE. THERE WAS AN APPROXIMATELY 15 MINUTE DELAY IN THE PROCEDURE WHILE ANOTHER DRILL WAS PREPPED. THE SURGEON USED THE SECOND DRILL TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS REPORTED. THIS IS 1 OF 1 REPORT FOR THIS EVENT FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156250 BATTERY REAMER/DRILL HTO SYNTHES GMBH 2951

    Patients

    Seq Age Sex Outcome Treatment
    1