BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3478702 · Received November 20, 2013

    Report

    Report Number
    1719045-2013-02072
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Report Date
    October 30, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE HAND PIECE FOR BATTERY POWERED DRIVER WAS MANUFACTURED BY TRIANGLE MANUFACTURING. ONE PART WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 05IF000008. 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 K OF SYNTHES DRAWING 05_000_008. SUPPLIER LOT NUMBER 002265. SYNTHES DHR 5880017. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4): THE ITEM WAS RECEIVED INOPERABLE. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE DUE TO MOTOR FAILURE. THE PREVIOUS SERVICE CONDITIONS OF MOTOR FAILURE ARE RELEVANT TO THE CURRENT COMPLAINED ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. ADDITIONAL EVALUATIONS STATES: THE DEVICE WAS RECEIVED WITH A CRACKED CONTACT PLATE AND THE MOTOR RUNNING SLOW. THE CUSTOMER REPORTED THE DEVICE RUNS INTERMITTENTLY. THE REPAIR TECHNICIAN REPORTED MOTOR FAILURE AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE HOUSING, CIRCUIT BOARD, MOTOR, AND MEMBRANE SWITCH FLEX CIRCUIT WERE REPLACED AS WELL AS ALL APPLICABLE COMPONENTS. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION ON MAY 6, 2014 AND RETURNED TO THE CUSTOMER ON MAY 8, 2014.

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED HAND PIECE FOR BATTERY, HAVING ISSUES. TWO WERE INOPERABLE, ONE RUNS CONSTANTLY, AND ANOTHER WORKS INTERMITTENTLY AND THE BUTTONS ARE HARD TO PUSH. NO CASE IMPACT. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THIS REPORT IS ON ONE RUNS CONSTANTLY, AND/OR WORKS INTERMITTENTLY AND THE BUTTONS ARE HARD TO PUSH. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603665 HAND PIECE FOR BATTERY POWERED DRIVER HXX SYNTHES MONUMENT 5880017

    Patients

    Seq Age Sex Outcome Treatment
    1