DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
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Catalog Number 511.701 |
Device Problem
Failure to Run on Battery (1466)
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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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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the device does not oscillate when burr is attached.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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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.Device is an instrument and is not implanted/ explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.
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Manufacturer Narrative
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(b)(4): subject device has been received and is currently in the evaluation process.A service history review was conducted.The report indicates that the device has not been serviced during the past 6 months.There is no information relevant to the current complaint issue.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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A service and repair evaluation was completed: the device failure reported by the customer could be confirmed.The service history review shows no previous service conditions relevant to the current complaint issue.The service technician noted the following action taken: the device has been serviced and functional testing has been performed in accordance with service manual.During the pre-repair diagnostic assessment the service technician identified the failure code as gear, broken, torn off.The service technician identified the probable root cause as normal wear.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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Search Alerts/Recalls
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