Safety Alert Or Field Safety Notices for DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

In December 2016 DePuy Synthes issued a Field Safety Notice (FSN) informing clinicians of the possibility of breakage of the PFNA Blade impactor handle. If the breakage goes unnoticed, any body fluids that get into the handle during use would pose a risk of cross-contamination to other patients.The manufacturer sent a second Field Safety Notice in April 2017 to hospitals that hadn’t replied to the first FSN.MHRA is issuing this Medical Device Alert to ensure that all hospitals are aware of the problem and that adequate action is taken to mitigate risks to patients.