Model Number 130790030 |
Device Problem
Fracture (1260)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 09/22/2020 |
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 a case at (b)(6) hospital today for a reverse shoulder (using the delta xtend prostheses) one of the heads of the locking screws snapped off making it obsolete and causing great delay to the case time itself.Eventually the surgeon had to cut the top of the head off using a small frag set as attempting a full extraction would have caused too much aggravation to the shoulder in an already complex case.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached photograph identified damaged screw fragments.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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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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