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.Device was used for treatment, not diagnosis.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 for the reported failure mode.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.It was observed that the implants were not present when sleeve was removed to check the configuration of the implants.Hence,the complaint cannot be confirmed and device functions as intended.Since the reported condition was not confirmed the root cause for the reported failure cannot be determined.A manufacturing record evaluation was performed for the finished device [3l87560] number, and no non-conformances were identified.At this point, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).
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