Catalog Number 07.02015.008 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2017-00146, and 3012447612-2017-00169.
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Event Description
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It was reported that three rods were found to be labeled as 50 mm length, but actually measure 55 mm in length.This was detected outside of surgery, so no surgical impact.This is report two of three for this event.
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Manufacturer Narrative
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The returned rods were examined.Investigation into the event and a review of the manufacturing records determined that the actual length of the rod, the part number etched on the rod, and the part number and description (including length) on the package label were all correct.However, the length etched on the rod was incorrect; the length was etched as 50mm instead of the actual and correct length of 55mm.The cause is attributed to a supplier manufacturing error during the etching process.
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Search Alerts/Recalls
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