Model Number 2544-01-006 |
Device Problem
Break (1069)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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During impaction of an attune cr cementless femur the femoral impactor broke in two pieces.The surgical tech immediately handed surgeon a mono bloc attune impactor and he finished impacting the femoral component onto the femur without incident.Time was extended by 10 seconds while the scrub tech reached for the second impactor.There was no debris left and all pieces were accounted for.There was no harm or detriment to the patient.
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Manufacturer Narrative
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Product complaint #(b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient).No code available is used to capture surgery prolonged.
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Search Alerts/Recalls
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