Additional narrative: udi: (b)(4).The lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed wear marks on the device.The laser markings were slightly faded.To test its functionality, it was tested on a sample rubber strip; as a result, the upper jaw was slightly loose when the jaws are closed; therefore, it showed that the jaws did not close normally and did not maintain the necessary pressure grip contributing to the holding issue.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.According with the visual inspection and the functional test result, this complaint can be confirmed.The possible root cause for the issue experienced can be attributed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually damage the jaw.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Visually inspect the instrument and check for damage and wear.Also, jaws and teeth should align properly.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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It was reported by the sales rep that the expressew iii w/o hook device was not ratcheting correctly.During in-house engineering evaluation, it was determined that the upper jaw was slightly loose on the device when the jaws were closed; therefore, it showed that the jaws did not close normally and did not maintain the necessary pressure grip contributing to the holding issue.There was no procedure nor patient involvement reported.No additional information was provided.
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