COMPR SRS HUMERAL COUPLER

Description of Event or Problem

It was reported that a total humeral replacement procedure was scheduled and initiated at a facility. During the procedure, it was identified that an essential implant component, the humeral coupler, was not available in the surgical case. The humeral coupler is a required component for total humeral reconstruction and functions as the bridging connector between the proximal and distal sub-assemblies. No alternate component within the system was available to replace its function. Due to the component's absence, the procedure was interrupted and could not be completed on the same day. The missing component was obtained and delivered the following day. The procedure was resumed the following day and was successfully completed. Multiple missing items and a complicated ordering process involving additions and cancellations of parts were identified as contributing factors. The component had reportedly been absent from the surgical case for some time prior to the event. The patient required additional medical/surgical intervention in the form of a staged continuation of the procedure over two days. The procedure was completed successfully. There was no allegation of device breakage or patient death. It was reported that no further information is available.

Additional Manufacturer Narrative

(b)(4).G2: Foreign - The event occurred in Germany.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.