Model Number 86PS0515 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
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 implant was not in the box.It appeared as that the implant had been used at a previous hospital and the scrub nurse had returned the empty box to the black/yellow shipper.Because the implant the surgeon wanted wasn¿t available he decided he had to drill a size bigger so he could use the 6mmx20mm g-force screw as he wasn¿t happy using the other size 5mm option of screw which was the 5mmx10mm screw due to the lack of length.A surgical delay of 3 minutes was reported.
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Event Description
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It was reported that the implant was not in the box.It appeared as that the implant had been used at a previous hospital and the scrub nurse had returned the empty box to the black/yellow shipper.Because the implant the surgeon wanted wasn¿t available he decided he had to drill a size bigger so he could use the 6mmx20mm g-force screw as he wasn¿t happy using the other size 5mm option of screw which was the 5mmx10mm screw due to the lack of length.A surgical delay of 3 minutes was reported.
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Manufacturer Narrative
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The reported event could be confirmed due to the information provided.Based on investigation, the root cause was attributed to a transport/storage related issue.The failure was caused by inadequate manual inspection of the product packaging.It appears the product was used previously and a manual check of the product packaging had not been undertaken fully.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A local nc was created to further investigate the issue.
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Search Alerts/Recalls
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