Catalog Number 9330034 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2014 |
Event Type
malfunction
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Manufacturer Narrative
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With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from small bone innovation, inc.(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The device is not available to stryker.
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Event Description
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Left/right compression screws were labeled (laser etched) incorrectly.The left screws fit into right nails and the right screws fit into left nails.Compression screws for lot 1331001 for part numbers 933-0033 and 933-0034 were confirmed to be assembled incorrectly.This lot of parts for both part numbers was reworked, restoring parts to their intended configuration of left hand and right hand.
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Manufacturer Narrative
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Manufacturing date was added.
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Event Description
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Left/right compression screws were labeled (laser etched) incorrectly.The left screws fit into right nails and the right screws fit into left nails.Compression screws for lot 1331001 for part numbers 933-0033 and 933-0034 were confirmed to be assembled incorrectly.This lot of parts for both part numbers was reworked, restoring parts to their intended configuration of left hand and right hand.
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Search Alerts/Recalls
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