Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is not currently available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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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It was reported by the sales rep that post-op an anterior cruciate ligament (acl) procedure, while cleaning the inner shaft of the extra large 30 mm sheath inserter, it was observed that a wire brush was stuck inside.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > according to the information provided, it was reported that during while cleaning the inner shaft a wire brush was stuck inside. the complaint device was received and evaluated.Visual observation reveals the distal end of the inserted looks fairly new but in used condition.The tip is slightly scratched, and evaluating it could not find any wire brush and without the foreign material inside the unit cannot verified.The possible root cause for the reported failure cannot be determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device 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.
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