Catalog Number 0580-1-440 |
Device Problems
Component Missing (2306); Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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It was reported that no laser etchings on exeter stem ref (b)(4) lot g6106543.
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Manufacturer Narrative
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An event regarding missing product markings involving an exeter stem was reported.The event was confirmed via a photograph supplied by the surgeon.The device was not returned for evaluation.Medical records received and evaluation: not performed as there were no medical records provided.No adverse consequences were reported for the patient.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.A capa investigation was conducted on the marking process.The investigation concluded, the device was not marked by the operator.
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Event Description
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It was reported that no laser etchings on exeter stem ref (b)(4), lot g6106543.
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Search Alerts/Recalls
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