Batch review performed on 16 march 2018 (b)(4).Visual inspection performed on mar 16, 2018 by cleaning and washing manager: both the outer and the inner blister containing the two involved femoral components received were found cracked during surgery.Moreover, the carton box also shows signs of damage.The third items involved in the case was not returned.According to internal procedures, the operator involved in the manufacturing process must 100% check the integrity of the whole package of each single item of the lot.Considering that it is implausible for the device to be released with such damage by medacta international (b)(4), the two following root causes could be evaluated: 1.Anomalous shipping conditions:considering the extent of the breakage, it can be reasonably excluded that the damage could have been generated by standard shipping methods.2.Accidental handling damage:it is possible that during handling/storage at the hospital an accidental event occurred resulted in the damage.Considering the points above, the most probable root cause could be found in accidental shipping/ handling damage.During the visual inspection, the pictures provided at the moment of the notification were evaluated, too, but they didn't add any further information to the analysis.
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When opening the implant, it was noticed that the inner packaging was compromised.The agent had a secondary implant, the packaging was damaged.The surgeon decided to down size to a size 5, the packaging on this implant was also damaged.The agent had the closest sales representative to drive another implant to the hospital.This implant was used to complete the surgery.There was a several hour delay in the case.It was a 10 hours case.The surgery was completed successfully.
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On mar 29, 2018 the third packaging (lot 155543) was analyzed and it was found less damaged than the other two already received.In detail, it showed only some dents on the inner blister, in correspondence of the area in which the hinge post could accidentally reach the blister inner surface if the package is not handled with caution.All the consideration done for the possible root cause of the other two implants packaging damaged received are confirmed also for this third one.
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