BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3127287 · Received May 23, 2013

    Report

    Report Number
    1719045-2013-01456
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE 03/11/2011. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS (DHR) REVEALED THE HAND PIECE FOR BATTERY POWERED DRIVER WAS MANUFACTURED BY TRIANGLE MANUFACTURING. THE ORIGINAL SYNTHES LOT NUMBER FOR THIS PART WAS 5402145, ON WHICH (B)(4) WAS GENERATED WITH (B)(4) FOR CRACKS IN THE CORNERS OF THE CONTACT PLATE. THE PART WAS RETURNED TO THE SUPPLIER. THE PART WAS LATER DISPOSITIONED ACCEPTABLE. THE PART WAS RETURNED TO SYNTHES AS LOT 5466973 AND WAS INSPECTED TO INSPECTION SHEET NUMBER (B)(4). THE PRODUCT CONFORMED TO ALL REQUIREMENTS. NO ADDITIONAL NCRS WERE GENERATED DURING PRODUCTION. THIS LOT WAS MADE TO REVISION ¿G¿ OF SYNTHES DRAWING (B)(4). SUPPLIER LOT NUMBER 001271. SYNTHES DHR¿S (B)(4).

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL EVALUATION SHOWS THAT THE ITEM WAS RECEIVED NON-WORKING. THE ITEM WAS RELEASED TO THE WAREHOUSE ON 3/11/2007, PURCHASED ON (B)(6) 2007, FORWARDED TO REPAIRS ON 4/20/2013, AND SHIPPED BACK TO THE CUSTOMER ON 4/29/2013. THE EVALUATION SECTION OF INSPECTION SHEET (B)(4) INDICATES THAT THE MOTOR WAS NOT FUNCTIONING. THE CIRCUIT BOARD, MOTOR/GEARHEAD, MEMBRANE SWITCH, FLEX CIRCUIT, AND ALL APPLICABLE PARTS WERE REPLACED AND DEVICE WAS RETURNED TO CUSTOMER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.(B)(4): THE ITEM WAS RECEIVED INOPERABLE. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT, DEVICES NOT FUNCTIONING OR ONLY FUNCTIONS INTERMITTENTLY. THE EVENT TOOK PLACE DURING SURGERY, AS WELL AS POST-OPERATIVELY. IT WAS ALSO REPORTED THE EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HAND PIECE FOR BATTERY POWERED DRIVER. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230344 HAND PIECE FOR BATTERY POWERED DRIVER HWE SYNTHES MONUMENT 001271

    Patients

    Seq Age Sex Outcome Treatment
    1