Model Number N/A |
Device Problem
Incorrect Device Or Component Shipped (2962)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a procedure, it was found the plate and screw inside the packaging did not match the label.Another plate and screw of the correct size were used to complete the procedure without delay.No further information has been provided.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.It was found the hiploc plate was incorrectly marked with the angulation and reference number.Investigation results concluded that the reported event was due to human error that occurred during the set up resulting in a correct marking of the lot number and an incorrect marking of the part number and the angulation.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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