Model Number 1100-08-100 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 05/18/2020 |
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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Intraoperatively the centric epiphysis sz.1 did not fit into the stem.Another stem was used and connected with the epiphysis without issues.Surgical delay < 15 minutes, no adverse consequences for patient.
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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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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.H10 additional narrative: added: d10, e1 (facility name).Corrected: h3, h6 (patient).H6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : evaluation of the returned device confirmed the reported event.The device was manufactured on 13-june-2016.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : product code 110008100, work order (b)(4) was manufactured on 13-jun-2016.(b)(4) parts were manufactured per specification and all raw materials met specification.(b)(4) parts were scrapped.1x a050 (deep tool marks).1x a564 (part mark 2d mark scrap).Both are unrelated to the failure mode of this pc.No parts were reworked.There was no non-conformance (nc) associated with this lot.
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Search Alerts/Recalls
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