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 medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
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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 additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: the manufacturer contact name has been updated as (b)(4) contact phone number and email address have been updated accordingly.Per service manual operational and diagnostic analysis confirmed reported issue (not reading the pressure correctly).Replaced worn finger on complete pressure adjuster with tip replacement kit as identified in the investigation to address the reported issue or the additional issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The possible root cause for the reported failure was thus identified as the worn finger for pressure adjustment.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot = this serial number belongs to an old legacy device.A review of lot/batch history for each legacy fms product complaint received by mitek is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.
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