Catalog Number 07.01748.001 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the tip of a screwdriver broken off during final tightening in surgery.The tip was retrieved from the patient.There were no patient impacts associated with this event.
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Manufacturer Narrative
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Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one returned driver for the failure of fractured tip.Medical records were not provided for review.Device evaluation: visual inspection revealed the tip has fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that the tip of a screwdriver broken off during final tightening in surgery.The tip was retrieved from the patient.There were no patient impacts associated with this event.
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Search Alerts/Recalls
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