The reported event that foot arch hoffmann lrf 180mm was alleged of 'instrument breakage identified out of surgery' could be confirmed, based on provided picture.Since the affected device was not returned and the lot number was not communicated, it is not possible to know according which revision the product has been manufactured.However, based on provided picture, we can confirm the affected device is not from revision c but from anterior revision (a or b); connection pins have a new design on revision c.Design change was performed for revision c of the drawing # 4934_6_100 (design change # sel 16-244) in order to increase the strength connection between metal and carbon parts of foot arch hoffmann lrf 180mm.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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