Please note correction to section b1 and b2.The reportability decision was revised to malfunction after completion of the investigation.Indeed, the investigation revealed a severity level of s2.According to our procedure an s2 severity level is not considered as serious injury.The reported event could be confirmed, since the devices are in the received condition not functional anymore.The device inspection revealed the following: the devices were returned in disassembled condition.The hexagon of the holding screw is strongly damaged, which was most likely caused during the forcible removal of the screw.Significant fretting marks running over the whole circumference were visible on the outer surface of the shaft of the nail holding screw (nhs) close to the beginning of the thread.In addition there is a strong deformation at the forefront visible, the deformation was most likely caused by a hit with another instrument.However, afterwards it cannot be defined if this damage occurred before or after the complained malfunction.The functional test has shown that it is not possible to fully insert the nail holding screw into the adapter anymore.The insertion of the holding screw stops at the pins at the forefront of the adapter.The relevant dimensions of the device were verified during the evaluation and no deviation from the specification could be detected.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 user related issue.The appearance of damage indicates that the devices got jammed by ¿cold welding¿ due to friction welding being caused by high surface pressure.Local surface pressure may arise when the items are assembled under misalignment.If more information is provided, the case will be reassessed.
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