Catalog Number 046W1AN00641 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/14/2021 |
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 off during surgery.Another driver was used to complete the procedure without reported patient impacts.
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Event Description
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It was reported that the tip of a final driver broke off during surgery.Another driver was used to complete the procedure without reported patient impacts.
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Manufacturer Narrative
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Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.This report is relaying additional information.Device evaluation: visual inspection revealed the tip of the device has fractured.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential cause: tip fracture or stripping of the final screwdriver shaft can occur when the driver is over torqued or when force is applied off-axis.Device use: this device is used for treatment.If additional information is received which changes the information provided in this report, a follow-up report will be submitted.
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Search Alerts/Recalls
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