Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that during the procedure, the middle part of the subject coil became invisible under fluoroscopy.The surgeon stated that there was possibility that the hub was overtightened when the coil was inserted, and the middle part of the coil was stretched.Additional information provided by the customer indicated that there was no allegation against associated devices used in the procedure, no damage was noted to the device packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was very tortuous, and no excessive force was applied while advancing the coil.In the case of this complaint, it is possible that overtightening of the rhv may have caused damage to the middle part of the coil when advancing it through and as a result the coil was not fully visible under fluoroscopy.The patient's tortuous anatomy may have also contributed to difficulties encountered during the procedure that may have resulted in the coil stretching.An assignable cause of procedural factors will be assigned to this complaint since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
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