Catalog Number 230H4001 |
Device Problems
Fracture (1260); Physical Resistance/Sticking (4012)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 07/08/2022 |
Event Type
Injury
|
Event Description
|
It was reported that a tether set screw driver jammed in the counter tensioner and was difficult to detach from the set screw intraoperatively.While cleaning the driver at the end of the procedure, the tip was found to have fractured off and is presumed to be retained within the set screw.There have not been any reported patient impacts associated with the retained fragment.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that a tether set screw driver jammed in the counter tensioner and was difficult to detach from the set screw intraoperatively.While cleaning the driver at the end of the procedure, the tip was found to have fractured off and is presumed to be retained within the set screw.There have not been any reported patient impacts associated with the retained fragment.
|
|
Manufacturer Narrative
|
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: visual inspection revealed that the tip was fractured.The base had minor scratches.Functional testing revealed that the device was able to attach and detach from a tether counter-tensioner multiple times without issue.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 zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied to the driver when it was being removed from the set screw.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
|
|
Search Alerts/Recalls
|