Catalog Number 6264-8-026R |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 04/08/2014 |
Event Type
malfunction
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Event Description
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At the bha surgery, after the final trial reduction with v40 head trial, when the trial head with outer head was took off, the doctor confirmed the trial head was broken.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding a fractured trial head involving a partnership trial head was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection confirmed the reported event.Material analysis was performed on the reported device, which concluded the proximal end of the trial fractured in overload.In addition, no material or manufacturing defects were observed.Medical records received and evaluation: not performed as medical records were not provided for evaluation.Device history review: review of device history records indicates the lot was manufactured and accepted into final stock free of discrepancies.Complaint history review: there has been (b)(4) other event for the lot referenced.Conclusions: the investigation concluded that the reported fracture was caused by multiple overload conditions.No manufacturing defects were observed.
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Event Description
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At the bha surgery, after the final trial reduction with v40 head trial, when the trial head with outer head was took off, the doctor confirmed the trial head was broken.
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Search Alerts/Recalls
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