Catalog Number 046W1AN00640 |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a driver tip was found broken during routine inspection.Therefore, no specific surgical or patient information is available.
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Event Description
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It was reported that a driver tip was found broken during routine inspection.Therefore, no specific surgical or patient information is available.
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Manufacturer Narrative
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The returned device was evaluated.Visual inspection revealed the tip is fractured.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The likely cause for fracture is due to over-torqueing or forces applied off axis.
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Search Alerts/Recalls
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