STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 4 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number 40-20904 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that the 4 distal holes ("clover shaped") of the small fibular plate did not have locking mechanisms, allowing screws to pass clean through the plate.A second plate was immediately available in the o.R.And was used with no surgical delay.
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Manufacturer Narrative
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The reported event that distal lateral fibula plate, 4 hole was alleged of 'no locking effect & not functional' could be confirmed.Based on investigation, the root cause was attributed to be manufacturing related.The failure was caused by human error.Due to this deviation, an nc was opened to investigate further.The device inspection revealed the following: the visual inspection of the plate shows that indeed, the locking mechanism is lacking in 5 of the distal holes.The 4 proximal holes have been welded correctly.The absence of the locking mechanism does indeed allow the screws to go through the holes with no contact.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 investigation report will be updated.
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Event Description
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It was reported that the 4 distal holes ("clover shaped") of the small fibular plate did not have locking mechanisms, allowing screws to pass clean through the plate.A second plate was immediately available in the o.R.And was used with no surgical delay.
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