It was reported that on (b)(6) 2023, the surgery was performed via tka for oa.In the surgery, a condyle fracture occurred during the trial placement and was fixed with screw.It was found that there are no screws at the facility, so they had to borrow from neighboring facilities.The surgery was completed successfully with 40 minutes delay.Doe: (b)(6) 2023.
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary = > an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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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