Catalog Number 532.010 |
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 Date 01/28/2014 |
Event Type
malfunction
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Event Description
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It was reported that a small battery drive was not functioning during an orthopedic trauma surgical procedure.There were no delays nor patient injury reported in the surgery.Another device was available and used to complete the surgery.(b)(4).
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Manufacturer Narrative
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This device was used for treatment, not diagnosis.(b)(4) is a supplier lot, synthes lot could not be verified.Device is an instrument and is not implanted / explanted.(b)(6).Investigation is on-going.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.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 was used for treatment, not diagnosis.Service history of the past six months from the awareness date was reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is unknown.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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Power tool evaluation was completed for this device.The customer's complaint that the (003268) small battery drive does not function was confirmed.The device was evaluated and the complaint was reproduced.It was also noted that it has worn coupling head, sticky trigger from normal use over time.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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