STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Model Number 3425-1380S |
Device Problem
Fracture (1260)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 08/27/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device retained by hospital.
|
|
Event Description
|
The customer reported there was a spontaneous fracture of the implantable medical device.Revision surgery was required to put the nail back in place.
|
|
Manufacturer Narrative
|
Please note correction to d4 lot number.The reported event could be confirmed based on images provided, only.A physical device inspection was not possible since the affected device was not made available for evaluation and thus, inspection was limited to the images available.Based on these images a broken nail was verified.The nail is completely broken in the webs of the proximal drill hole for the lag screw.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history did not indicate any abnormalities.No corrective actions are required at this time.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
|
|
Event Description
|
The customer reported there was a spontaneous fracture of the implantable medical device.Revision surgery was required to put the nail back in place.
|
|
Search Alerts/Recalls
|
|
|