STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE
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Model Number 657312S |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation any additional information will be communicated in a supplemental report.
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Event Description
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It was reported what while inserting the screw, something like an iron powder substance was found.No adverse consequences to the patient were reported.
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Event Description
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It was reported what while inserting the screw, something like an iron powder substance was found.No adverse consequences to the patient were reported.
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Manufacturer Narrative
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The reported event could be confirmed, since metal chips were returned with the screw.The device inspection revealed the following: the screw was returned with two metal chips enclosed, most likely are these chips the in the complaint description mentioned iron powder.One of the chips is very thin and is not visible to the naked eye.The other chip is bigger and can be recognized without magnification.The microscopic inspection has shown that the bigger chip was peeled off from the locking thread at the head of the screw, while the smaller chip was peeled off from the thread at the shaft of the screw.At all damages is the anodized layer worn away which shows that they were caused post-manufacturing.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an excessive contact between the screw and the plate, which did lead to the separation of the material.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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