Catalog Number 47249536011 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi: (b)(4).Concomitant medical products: tibial connecting bolt tall cat# 00249000507 lot# 63702945; tibial targeting guide handle tall cat# 00249000513 lot# 63579873.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02631, 0001822565 - 2020 - 02632.
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Event Description
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It was reported that during trauma surgery the tall jig and locking/connecting bolt would not lock into the nail.The connecting bolt does not turn freely in the jig and would not connect to the nail.This caused the surgeon to drop the nail.Case was completed with the phoenix nail with no issues.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, the device was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, the device was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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