It was reported via medwatch from received from fda.The surgeon was doing a knee scope with meniscal repair, loaded the omnispan meniscal repair 12 degree onto the deployment gun.As surgeon was adjusting gun to the correct location, metal tip of the repair system came off deployment gun and was loose in the patient's knee.The result was an additional small incision to remove the loose metal tip.
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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 meniscal deployment gun was received and evaluated.It was observed under magnification and observed that tip was broken.The complaint can be confirmed.From the information provided the root cause for the reported failure cannot be determined.No lot number was provided which precludes in conducting a manufacturing record evaluation.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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