Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 mdr will be submitted.
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Event Description
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It was reported that during a primary case there was an issue with the g7 straight handle inserter and the threads came off during impaction.To complete the procedure a curved impactor was used.There was no delay in result of the broken straight handle.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional information on the reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed via pictures.Visual examination of the provided photos identified an inserter with broken threaded end displayed as well as attempt to show item and lot number that was blurry.No product was returned; dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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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Search Alerts/Recalls
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