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Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the rib plate malfunctioned and resulted in a retained foreign body during implantation.The surgeon was using the rib plates for repair of multiple rib fractures.The surgeon proceeded to tighten the locking caps and noticed the plate separated from the locking post.This happened to only one of the posts.They were able to unscrew the other side and remove the plate, but couldn't remove the post, cap, and washer on the broken side.The malfunction resulted in a surgical delay that exceeded thirty (30) minutes.It was reported that no further information is available.
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Device was not returned for evaluation.No product was returned; therefore, visual and dimensional evaluations could not be performed.Visual examination of the provided pictures identified the plate separated from the post, with components embedded in the tissue.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information which would change or alter any conclusions or information, a supplemental report 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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