Product complaint # pc-(b)(4).It was documented in the initial medwatch report that the expiration date was unknown.The expiration date (feb 28, 2023) has been updated.The unique identifier (udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.All parts of the device were attached.The wire of the device was bent perpendicular to the elbow tube.When the surgeon was attempting to pull the suture out of the patient's body, the wire may have bent out of its intended shape due to the tension of the suture.Therefore, a potential root cause for the reported failure may be use misuse applying excessive tension to the suture.However, we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).
|