STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM; PLATE, FIXATION, BONE
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Model Number 657350S |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "during the screw insertion of the distal humerus, what seems to be a thread has come off, the screw was replaced it with a new screw".
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Event Description
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As reported: "during the screw insertion of the distal humerus, what seems to be a thread has come off, the screw was replaced it with a new screw.".
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Manufacturer Narrative
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The reported event could be confirmed, since the device inspection shows some material shearing on the implant.The visual inspection of the returned device shows clear deformation of the threads in the middle of the screw.A microscope inspection clarifies that some of the thread material was torn apart from the screw.The most probable root cause for this event is if the screw rubbed against the plate¿s material during insertion.This could have resulted in the material of the thread to shear away from the rest of the implant.The rubbing was most probably due to the insertion of the screw with an angle greater than the 30° cone allowed by the system.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the insertion of the device with an inappropriate angle.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
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