STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM; PLATE, FIXATION, BONE
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Model Number 657318S |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by the hospital.
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Event Description
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As reported: "locking screw did not lock during the operation for clavicle(right side).The surgeon's view for the cause was unknown.It may be too angled, but the reporting sr thought it was within the acceptable range.".
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Event Description
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As reported: "locking screw did not lock during the operation for clavicle (right side).The surgeon's view for the cause was unknown.It may be too angled, but the reporting sr thought it was within the acceptable range.".
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A potential non-conformity report was initiated to address similar events in the past.The comprehensive root cause analysis of the potential ncr included a surface and microstructure analysis as well as nano-indent hardness measurement of variax1 and variax2 screw samples by the fraunhofer institute on behalf of stryker.Further internal investigation efforts were focusing on the anodization color difference between variax1 and variax2 screws.Significant differences between the screws which could result in the reported complaints have not been revealed in either fraunhofer or stryker investigations.Excessive in-house handling and bench testing with variax2 screws from various manufacturing batches showed that locking is achieved as intended.The desired increase in torque indicating to the customer that the screw is locking in the plate, can be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Considering the information given and based on the above investigations a root cause of the reported event could not be determined.If any further substantial information is provided, the investigation report will be updated.
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