Catalog Number UNK KNEE TIBIAL INSERT |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 on (b)(6) 2024.The ms insert was used in the surgery.The circulating nurse opened the ms insert, took it out of the outer packaging, and the instrumentation nurse tried to take it out by grasping it with a locking hemostatic forceps, etc.However, it was difficult to take out the ms insert because the cover on the top has no grooves or protrusions and there is no gap.The ms insert almost became unclean while being taken out.No further information is available.
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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.An evaluation of the manufacturing record could not be performed, as the required product/lot number was not provided to complete the evaluation.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: the device lot number is unknown.Therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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