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.Investigation summary according to the information provided, it was reported that the dual stopcock sheath was extremely tight and the obturator can barely fit.The device was received and evaluated.When performing the visual inspection, it could be observed that the mitek lock button is missing, a straight ruler was used to review the device tube for bending, it was found that the device is slightly bent at the distal end.According with the visual inspection result, we can confirm this complaint.A possible root cause can be attributed to the handling of the device, since this device is reusable, the metal parts are expected to have some structural changes due to rough and repeated use and sterilization process.The lock button could have been lost during the cleaning and drying process.However, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device (b)(6) and no non-conformances were identified.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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