DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010 |
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 02/17/2017 |
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 unspecified surgical procedure, it was discovered that the small battery drive device operated intermittently.
The reporter stated that the battery was replaced with another but yielded the same result.
The amount of delay to the surgical procedure was unknown.
A spare device was used to complete the surgical procedure.
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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Manufacturer Narrative
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The actual device was returned for evaluation.
Reliability engineering evaluated the device and observed that the device passed all operational specifications.
Therefore, the reported condition was not confirmed.
An assignable root cause was not determined.
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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