BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3127273 · Received May 23, 2013

    Report

    Report Number
    1719045-2013-01457
    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 MANUFACTURE DATE 03/11/2011. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE HAND PIECE FOR BATTERY POWERED DRIVER WAS MANUFACTURED BY TRIANGLE MANUFACTURING. THE ORIGINAL SYNTHES LOT NUMBER FOR THIS PART WAS 5413084, ON WHICH MRR 121572 WAS GENERATED WITH STOCK EVAL 937 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 5466906 AND WAS INSPECTED TO INSPECTION SHEET NUMBER 05IF000008. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. NO ADDITIONAL NCRS WERE GENERATED DURING PRODUCTION. THIS LOT WAS MADE TO REVISION ¿H¿ OF SYNTHES DRAWING 05_000_008. SUPPLIER LOT NUMBER 001317. 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 4/24/2007, FORWARDED TO REPAIRS ON 4/20/2013, AND SHIPPED BACK TO THE CUSTOMER ON 4/29/2013. THE EVALUATION SECTION OF INSPECTION SHEET 530FI405 REV ¿K¿ 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 IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. 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. BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    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.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    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 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228827 HAND PIECE FOR BATTERY POWERED DRIVER HWE SYNTHES MONUMENT 001317

    Patients

    Seq Age Sex Outcome Treatment
    1