Model Number 2217-50-041 |
Device Problem
Break (1069)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 10/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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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The surgeon was impacting a definite acetabular cup during a primary total hip replacement when the end of the impaction handle broke off.There were no small fragments created.The surgical site was deemed free of debris and the procedure continued.Surgical delay 2 minutes.Procedure successfully completed.
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Manufacturer Narrative
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Product complaint # (b)(4).Examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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