The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.This mdr is being submitted as a part of a remediation effort the company has undertaken.
|
After further review of additional information received the following sections a1, b3.November/december 2016, b4, b5, b6, b7, d1, g1, g3, g7, h1, h2, h3 and h6 have been updated accordingly.The company investigation shows that the root cause of this event is that the stem protector was not removed and was left in the patient, thus necessitating revision.No corrective action was taken because instruction to remove the stem protector was included in the operative technique.The operative technique guide states to remove the humeral stem protector and assess the position of the stem's spherical bore in relation to the resected surface of the proximal humerus.It is also noted in labeling in the warnings and precautions- only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about all aspects of the shoulder system surgical technique and use these implants in accordance with the respective indications and contraindications.In addition, the surgeon should be fully knowledgeable about the compatibility of system components and use each device accordingly.Finally, the surgeon must be fully knowledgeable about surgical technique, and he/she must be trained according to the proper use of the system instrumentation.This device is used for treatment not diagnosis.Information about this event has been requested, no new information has been provided.No information: a2-6, d4.Without catalog numbers we cannot obtain the 510(k).Without serial/lot numbers we cannot obtain manufacture date.Corrected data: brand name.Not a facility.
|