STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L34MM; PLATE, FIXATION, BONE
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Model Number 657334S |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
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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"it was reported that during surgery the nurse found the foreign material in the sterile pack for this item when they open the packaging.The foreign material was 4mm cubic, was seemed a rubber.The new screw was used for the surgery and it was successful.".
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Manufacturer Narrative
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The reported event could not be confirmed.The part was received including the foreign material.Therefore, a ftir analysis was completed on the unknown contaminant on screw packaging.The top match to the contaminant of interest at a 93.42% match to ¿3m brand spray 80 rubber and vinyl adhesive¿.Stryker initiated a second ftir test with actual reference materials from the operation environment and the result differs from the result of the initial test performed on the contaminant.The ¿foreign material¿ was clearly linked to a latex material which is used typically in cleanrooms and or-environment.Based to the fact that the returned sample was opened it also has to be assumed that the latex particle source is from the or-environment.Therefore, the reported event is a user related issue.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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Event Description
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"it was reported that during surgery the nurse found the foreign material in the sterile pack for this item when they open the packaging.The foreign material was 4mm cubic, was seemed a rubber.The new screw was used for the surgery and it was successful.".
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