Catalog Number 05.000.008 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported that the two hand pieces for battery powered drivers were not working in the operating room.Both devices did not have power.There was no delay to the surgical procedure or patient harm.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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Additional device product code is gxl.Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device service history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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A service and repair evaluation was performed ¿ the customer reported the device was not working.The repair technician reported the motor was seized.Motor failure is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.This item was repaired, passed synthes final inspection and returned to the customer on (b)(4) 2015.The evaluation was confirmed.A service history review was performed ¿ a service history of the past three years has been reviewed.The item was previously returned for service on (b)(4) 2012 due to motor failure.The customer called in a service request for this item on (b)(4) 2015 and reported that the device is inoperable-does not work.The previous service condition of motor failure is relevant to the current complained issue of the device is inoperable-does not work.The manufacture date of this item is 14-jan-2010.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Additional information provided - there were other parts available to complete the surgery.
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Search Alerts/Recalls
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