smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

The firm disseminated a medical device field correction notice on 11/11/2019 by letter. The letter explained the failure and requested the following actions be taken by hospital representatives: 1. Please check your inventory and complete the attached Inventory Correction Certification Form. 2. If you have the PROFIX 750 Gram Mallet, please maintain awareness of this notice. 3. When preparing for cleaning, disassemble the poly tip from the mallet and inspect disassembled components for damage or wear. 4. After cleaning, inspect disassembled components and ensure the components can be re-assembled securely. 5. Ensure the PROFIX 750 Gram Mallet is sterilized in the disassembled state. 6. After sterilization, ensure the poly tip is re-assembled to the mallet securely.