Catalog Number 130790036 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/16/2023 |
Event Type
malfunction
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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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Event Description
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It was reported that the screw broke during use.The surgeon was not able to remove the remaining part of the screw.Did this delay surgery time: yes, by 20 minutes.Injury to patient: no.
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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.A manufacturing record evaluation was performed for the finished device product 130790036, lot 5570656, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device product 130790036, lot 5570656, and no non-conformances / manufacturing irregularities were identified.
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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.A manufacturing record evaluation was performed for the finished device product 130790036, lot 5570656, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device product 130790036, lot 5570656, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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