SYNTHES OBERDORF SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.103 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
(b)(6).
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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 from (b)(6) that during an open reduction internal fixation of an ankle fracture, it was observed that the battery device had an intermittent power.
According to the reporter, the battery was replaced with an identical spare device and completed the case.
It was further reported that the device was being used for treatment.
There was patient involvement.
There were no reports of injuries, medical intervention or prolonged hospitalization.
All available information has been disclosed.
If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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