The reported event could be confirmed, since the returned device is not functional as required anymore.The device inspection revealed the following: the targeting arm was returned for evaluation.The visual inspection of the nail adapter interface has shown that the surface is strongly worn, which indicates that the device was often and intense used.The glass-fiber reinforced part of the targeting arm is in a good condition with just slight wear marks, the markings are good readable.A functional test was conducted, but after the nail adapter was attached to the targeting arm it was directly noticed that the adapter is slightly movable at the end.The movement was caused by some play between the metal locking mechanism and the glass-fiber reinforced part at the targeting arm.The detected movement of the nail adapter has clearly an influence on the aiming accuracy of the system and the complaint can therefore be rated as confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.The event was caused by a combination between high torsional loads during use and wear over the years at this in the year 2012 manufactured device.In general following statements of the instructions for use can be pointed out in relation to this complaint: ¿ before every operation, ensure that all devices to be used during the operation function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure." if more information is provided, the case will be reassessed.
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