(b)(4).Concomitant products: screw catalog#:115383 lot#:552680, screw catalog#:180500 lot#:836390, screw catalog#:180500 lot#:669780, screw catalog#:180501 lot#:730570, screw catalog#: 180502 lot#:605670, glenosphere catalog#:115320, lot#:890140, pin catalog#:405800 lot#: 914650, drill catalog#:405889 lot#:209110, drill catalog#:405883 lot#:316690, taper catalog#:118001 lot#:927470, baseplate catalog#:115330 lot#:926700, bearing catalog#:xl-115366 lot#:585890, stem catalog#:113631 lot#:423170, tray catalog#: 115340 lot#: 983880.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04550, 0001825034-2017-04588.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It is reported that during a reverse total shoulder arthroplasty revision procedure, the taper from the fractured humeral tray was stuck in the stem and the removal tool was not able to remove it after several attempts.As a result, it became necessary to remove the humeral stem.During stem removal, the stem extractor instrument fractured.The surgery was completed by using a small drill bit to remove bone from the proximal end of the stem and used vice grips to remove the stem.A new stem of the same size and a +5 bearing and new tray were implanted to complete the procedure.This malfunction ended up causing an approximate delay of thirty five (35) to forty five (45) minutes in the procedure.
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It is reported that during a reverse total shoulder arthroplasty revision procedure, during stem removal, the stem extractor instrument fractured.The surgery was completed by using a small drill bit to remove bone from the proximal end of the stem and used vice grips to remove the stem.All device fragments were retrieved.A new stem of the same size and a +5 bearing and new tray were implanted to complete the procedure.The physician admits to having hit the instrument prior to fracture.
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