STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Model Number 3066-0095S |
Device Problems
Material Deformation (2976); Migration (4003)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 09/14/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
|
|
Event Description
|
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
|
|
Event Description
|
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
|
|
Manufacturer Narrative
|
The reported event was confirmed on provided x-rays.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential implant cut-out had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation resp.Support in order to relieve the nail during the implantation period.The labelling points refers in detail to the procedure steps for u-blade lag screw treatment.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a gamma3 u-blade set had protruded through the femur head after an implantation period of allegedly less than 7 weeks.The product was not available for investigation.Received medical documents (including x-rays) revealed the product-id.A medical statement was possible because a second view (in m-l-direction) was not available.Cut out is a typical complication of proximal femoral nailing.This harm does not primarily depend on the implant.It is mostly caused by the kind of fracture, patient's general condition and primarily the respective surgical technique.In this case the root cause was regarded as patient related.In case the item or further substantive information becomes available we reserve the right to reopen the investigation with new root cause assessment.
|
|
Search Alerts/Recalls
|
|
|