Catalog Number 07.02119.001 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/04/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the tips of a vital mis t20 starter and final driver fractured intra-operatively.There was no reported patient impact.This is report two of two for this event.
|
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
|
|
Manufacturer Narrative
|
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2023-00402.
|
|
Event Description
|
It was reported that the tips of a vital mis t20 starter and final driver fractured intra-operatively.There was no reported patient impact.This is report two of two for this event.
|
|
Manufacturer Narrative
|
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip is twisted and cracked.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 during use.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 (b)(6) control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
|
|
Event Description
|
It was reported that the tips of a vital mis t20 starter and final driver fractured intra-operatively.There was no reported patient impact.This is report two of two for this event.
|
|
Search Alerts/Recalls
|