Catalog Number 856206004 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
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Event Description
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It was reported an alps fibula anatomic plate was opened during surgery and the consultant wanted to contour it.While contouring the distal tab, it broke in the surgeons possession.There was no impact to patient safety but did result in a small delay in surgery.
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Manufacturer Narrative
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Device history record was reviewed and no discrepancies were found.Per the surgical technique: bending the distal tab beyond 20 degrees may result in breakage.Continuous bending will also fatigue the tab and cause it to break.From follow up information it is unknown if the plate was bent beyond 20 degrees or not.Therefore, a definitive root cause cannot be determined.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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