The reported event that reconstruction plate, straight holes 7 length 84mm for screws 3.5/4.0mm was alleged of 'wrong device used' could be confirmed only according to the given feedback from the hospital, despite that the product was not returned.Based on investigation, the root cause was attributed to be user related.The failure was caused by an user error as the wrong plate was taken out of the tray and used (a recon plate instead of a waisted compression plate).Original statement from our medical expert: more detailed information should be known in order to be able to give a sound answer to this occurrence.In general i would think that no major problems are associated with this wrong choice.In some cases the plates have to be bend for final exact fixation anyway but in the end the doctor and the other hcp involved are responsible which device they use.A review of the device history was not possible because the lot number was not communicated.Note that this only happened in this particular hospital, therefore the relevant hospital staff needs to undergo a training (¿user ¿ customer - learning gaps errors; lack of knowledge skills¿) in order to eliminate such problems.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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