BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3286475 · Received August 14, 2013

    Report

    Report Number
    1719045-2013-01884
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Report Date
    July 16, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GZL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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) FOR THIS LOT HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION STATES THE ITEM WAS RECEIVED WORKING INTERMITTENTLY.THE REPAIR TECHNICIAN REPORTED MOTOR FAILURE AS THE REASON FOR REPAIR. THE CAUSE OF THE MOTOR FAILURE IS UNKNOWN. THE MOTOR, MEMBRANE SWITCH/FLEX CIRCUIT, AND CIRCUIT BOARD WERE REPLACED AS WELL AS ALL APPLICABLE COMPONENTS. THERE ARE NO KNOWN NCRS ASSOCIATED WITH THIS PART AND LOT NUMBER. THIS ITEM WAS REPAIRED ON 4-OCT-2013 AND RETURNED TO THE CUSTOMER ON 7-OCT-2013.

    Additional Manufacturer Narrative · 1

    (B)(4): A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN PERFORMED. AS A RESULT, THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THEREFORE NO SERVICE HISTORY REVIEW CAN BE PERFORMED. INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE IS NOT FOUND.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE HAND PIECE FOR BATTERY POWERED DRIVER WAS MANUFACTURED BY TRIANGLE MANUFACTURING. 1 PART WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4). THE PRODUCT CONFORMED TO ALL REQUIREMENTS. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT WAS MADE TO REVISION ¿M¿ OF SYNTHES. SUPPLIER LOT NUMBER 003454. SYNTHES DHR 003454.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND PIECE FOR BATTERY POWERED DRIVER WORKED INTERMITTENTLY DURING UNKNOWN SURGERY ON UNKNOWN DATE. THIS IS NOT FOR A WARRANTY REPLACEMENT ONLY. THE DEVICE DID MALFUNCTION DURING SURGERY WITH MINIMAL DELAY AND NO PATIENT IMPACT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391015 HAND PIECE FOR BATTERY POWERED DRIVER GZL SYNTHES MONUMENT 003454

    Patients

    Seq Age Sex Outcome Treatment
    1