Smith & Nephew (NYSE:SNN) initiated a field safety corrective action to update its Profix 750 grams mallet cleaning and sterilization guide after complaints regarding a potential failure mode associated with the use of the mallet, used in surgeries.
Profix supplier Signal Medical received complaints regarding the failure mode in which the poly tip of the mallet may become loose and/or come off during use. If that occurs, particles in the poly thread could potentially enter the surgical field or a delay in surgery could occur, according to the notice issued earlier this week.
The failure mode may occur if the poly tip is removed during sterilization and is not fully screwed at the base of the mallet once reassembled before use in surgery. The tip is fitted to the base of the mallet body with a poly thread and, once screwed down, its relieved portion rests on the mallet body and is designed to absorb the force of the blow during use.
If the tip is not fully screwed, it may cause the force of the blow to be absorbed by the poly thread, which could cause the thread to strip, resulting in particulate formation. Repeated failures to fully screw in the tip can cause the thread to fail.
London-based Smith & Nephew sent the notice to additionally remind users that the poly tip must be removed for cleaning and sterilization. If that is not done, proper sterilization may not be completed and there may be a risk of infection from the mallet.
The company urged users to inspect their inventory and complete a return slip for Smith & Nephew if they have affected products. The affected Profix 750 gram mallets were shipped between Feb. 6, 2017 and April 5, 2019. Smith & Nephew said it has reported the field action to the relevant authorities.