BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 3852127 · Received June 5, 2014

    Report

    Report Number
    8030965-2014-00426
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    August 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION: LOT # PROVIDED IN THE INITIAL MEDWATCH IS THE SUPPLIER LOT#, SYNTHES LOT# IS 5406146. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADD'L PRO CODE: MOQ. THE DEVICE IS A POWER INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). (B)(4). A SYNTHES POWER TOOL EVALUATION WAS COMPLETED ON OCTOBER 10, 2013. IT WAS NOTED, THE REPORTER'S COMPLAINT THAT THE UNIT DOES NOT FUNCTION PROPERLY WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. THE EVALUATING ENGINEER NOTES, EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. CONCOMITANT PRODUCT: REMOVED BATTERY REAMER/DRILL. CHANGE TO NONE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORTED EVENT IS FOR ONE POWER DEVICE INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    FACILITY REPORTS THAT THE BATTERY REAMER-DRILL WAS NOT GETTING A GOOD CONNECTION; THE REPORTER IS UNSURE IF IT IS THE BATTERY OR THE SWITCH CONNECTION. THERE IS NO INFORMATION REPORTED REGARDING TIMING OF EVENT OR PATIENT INVOLVEMENT. NO INJURIES OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION REPORTED. UPDATE: FACILITY REPORTS EVENT OCCURRED DURING UNKNOWN SURGICAL PROCEDURE. IT IS REPORTED OR STAFF OPENED ANOTHER DRILL AND CONTINUED THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329918 BATTERY REAMER/DRILL MOQ SYNTHES GMBH 5406146 3026

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY REAMER/DRILL