Catalog Number 05.000.008 |
Device Problems
Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.A service and repair history record review was performed for the subject device.A service history of the past three years has been reviewed but could not be completed as the subject device has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is december 15, 2006.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.The subject device has been received and is currently in the evaluation process.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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It was reported that two hand pieces for batter powered drivers were functioning intermittently during a surgical procedure on an unknown date.It was reported that the first device's motor was slipping when the driver blade was attached and the surgeon was pressing the "forward" button.A second device was available and it was reported that it appeared to have the same issue as the first.The surgeon opted to use both devices in the "locked" position and the surgery was successfully completed with no adverse effect to the patient and no report of surgical delay.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Investigation summary: it was reported that two hand pieces for battery powered driver (05.000.008 lots 5394644 and 004774) were not functioning as intended.In each instance the motors were running intermittently.The returned devices were sent to service and repair for investigation where the following conditions were noted: ¿ran slow¿ ¿ lot 5394644 and ¿contact plate shows sign of impact on one corner, nose piece and coupler burred and will not accept driver, runs slow in fast forward and reverse¿ ¿ lot 004774.In each instance the device was unable to be repaired and was scrapped.It was reported that two hand pieces for battery powered driver (05.000.008 lots 5394644 and 004774) were not functioning as intended.In each instance the motors were running intermittently.The service and repair technician was able to confirm the complaint condition.The instruments were forwarded to customer quality as they were not repairable.A service and repair evaluation were performed: the customer reported the motor was slipping when the driver blade was attached and the forward button was pressed.The repair technician reported the device was running slow.Running slow is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was 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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Manufacturer Narrative
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Device history record review: release to warehouse date: december 15, 2006 no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Device 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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Search Alerts/Recalls
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