Catalog Number 500-03-52D |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Rep reported the following event : "tritanium acetabulum plug screw impossible to fit on the screwdriver.What steps have been taken to complete the intervention: screw not installed".
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Manufacturer Narrative
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An event regarding assembly issue involving an other hip plug was reported.The plug was packaged with a tritanium shell, catalog 500-03-52d.Assembly issue was not confirmed however damage to the device was confirmed after examination by materials engineer.Method & results: product evaluation and results: visual inspection of the returned device noted the following: high degree of damage observed on the driver attachment feature of the plug.Damage is consistent with contact against a hard object and attempted use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical information was received for review product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Rep reported the following event : "tritanium acetabulum plug screw impossible to fit on the screwdriver.What steps have been taken to complete the intervention: screw not installed".
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Search Alerts/Recalls
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