Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 01/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the pin driver was broken while removing the pins, and the broken piece was retrieved.
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Event Description
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No further information is available at the time of this reporting.
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Manufacturer Narrative
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Examination of the returned device confirms the reported material fracture.Material science evaluation determined the device fractured from overload.The device is conforming to its specifications.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause is undetermined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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