Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was discovered that the 2d barcode on the product label would not scan due to a missing digit.A review of the barcode data demonstrated that the gtin on the product is incorrect in the encoded data, resulting in the barcode not being interpreted correctly by the 2d scanning system.The barcode is added for ease of data transfer of the udi required material present on the label.The labels also include the information in a 1d barcode and human readable text, both of which contain the correct information.The 2d barcode issue was found to have existed since the product was launched.Classic wire cut is the physical manufacturer and label creator for this product.The supplier opened a capa for this issue and a change order was created to correct the issue.A product issue assessment was opened to further investigate the issue.No further action is warranted at this time.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).
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