This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Occupation: initial reporter is a synthes sales representative.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause for the reported problem could be fair wear and tear due to age and use.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.At this point in time, 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.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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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Conclusion codes: upon further investigation, it was determined that the conclusion code on the initial report was inaccurate.Therefore, the conclusion code has been updated to state that the cause was not established to reflect the correct information.Investigation summary the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause for the reported problem could be fair wear and tear due to age and use.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, 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.
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