Catalog Number 629246 |
Device Problems
Detachment of Device or Device Component (2907); Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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It was reported that the patient's left distal humerus was revised.The proximal end of the plate pulled off the bone.Three screw heads passed through the holes in the plate and remained in the bone.Surgeon reported that no trauma had taken place prior to revision.
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Manufacturer Narrative
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The reported event could be confirmed based on the provided x-rays as well as the returned device.The device inspection revealed the following: severe rupture at 3 screw holes where bone screws were inserted into the plate.The screw holes were ruptured inwards consistent with the result of forced entry through the plate screw holes by the screw head.The hexagonal inserts on the 3 screw heads also showed reasonable damage consistent with mis-alignment of screwdriver head during screw insertion or extraction.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of excessive load on the implant or trauma.If any further information is provided, the complaint report will be updated.
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Event Description
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It was reported that the patient's left distal humerus was revised.The proximal end of the plate pulled off the bone.Three screw heads passed through the holes in the plate and remained in the bone.Surgeon reported that no trauma had taken place prior to revision.
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Search Alerts/Recalls
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