STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Model Number 3066-0105S |
Device Problems
Positioning Failure (1158); Migration (4003)
|
Patient Problems
Failure of Implant (1924); Perforation (2001)
|
Event Date 07/06/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Upon completion of investigation, additional information will be provided in a supplemental report.
|
|
Event Description
|
As reported: "during lag screw did not slide, and it penetrated the femoral head.The surgeon it could be due to the set screw.".
|
|
Manufacturer Narrative
|
Correction: refer to b2, h6 device code.The alleged event could be reproduced based on the damage patters on the surfaces of the unbroken returned products.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.According to found surface pattern the event was initially caused by inappropriate placement of the set screw resulting in uncontrolled lag screw motion towards medial.The surgeon¿s opinion, event occurred due to the set screw, was confirmed.Inappropriate implant placement was regarded as user related.A product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
|
|
Event Description
|
As reported: "during lag screw did not slide, and it penetrated the femoral head.The surgeon it could be due to the set screw.".
|
|
Search Alerts/Recalls
|
|
|