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.H10: additional narrative: b1, b2, e1, d10.H6: patient code 3191 used to capture surgical intervention being required.H3, h6: investigation summary: the device was received and evaluated at the service center.The reported complaint by the customer was confirmed.It was found that the camera head was physically damaged.The damaged device was replaced as it was deemed not repairable.User mishandling is one possible cause which could have caused the physical damage to the device.However, given the information provided we cannot discern a definitive root cause for the same.No non-conformances were identified for this part (242400) - lot number (om02019) combination.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.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.
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