Model Number 2544-00-525 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/21/2023 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, the surgery was performed via tha for oa with the products in question.In the surgery, the products was used for sizing after distal femoral osteotomy.The size locking knob of the products in question did not move smoothly up and down.The surgery was completed successfully within 30 minutes delay.The investigation report is required.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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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 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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