Catalog Number UNKNOWN |
Device Problem
Mechanical Jam (2983)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 during a revision procedure that the tibial nail could not be removed.It was jammed in the tibia.There was a surgical delay of four hours due to multiple attempts at removing the nail.
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Manufacturer Narrative
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(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.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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