Catalog Number 046W1AN00640 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2018 |
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 the tip of a final driver broke during tightening within surgery.An alternative driver was used to complete the procedure without reported patient impacts.
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Manufacturer Narrative
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Udi number: (b)(4).The driver was not returned so an evaluation was unable to be performed.Therefore, there are no results available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues that would have contributed to this event.
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Event Description
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It was reported that the tip of a final driver broke during tightening within surgery.An alternative driver was used to complete the procedure without reported patient impacts.
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Manufacturer Narrative
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The returned device was examined.The tip was fractured and twisted consistent with blocker removal.The cause is likely related torsional failure during removal or not fully being seated.
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Event Description
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It was reported that the tip of a final driver broke during tightening within surgery.An alternative driver was used to complete the procedure without reported patient impacts.
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Search Alerts/Recalls
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