DePuy Synthes Impactor for PFNA blade recalled over risk of infection

Manufactured by Synthes, the DePuy impactors used for Proximal Femoral Nail Antirotation (PFNA) have been recalled over potentially dangerous risks of infection. PFNA’s are metal devices inserted into the femur bone to strengthen it.

The U.K.’s Medicines and Healthcare Products Regulation Agency (MHRA) has noted a defect with the medical device as a crack in the weld of the handle. The recalled blade is used to insert and position the PFNA in the centre of the bone, and the operating physician uses the handle to grip and position the attached PFNA. It is the handle for the PFNA Blade impactor that can crack, and continued use may mean bodily fluids like blood or bony debris can get inside the device, risking cross-contamination when it’s used for other patients.

Risks of cross-contamination

This contamination can be very dangerous as patients can carry diseases or bacteria that could cause great harm to other patients. As the patients are likely to be elderly or those with weaker bone densities, they could be more vulnerable to contracting illnesses. The contamination can make infection highly likely, and depending on the infected patient’s immune system, it could cause serious danger to health and life.

The field safety notice also notes that the handle can completely detach from the instrument, which in itself may be very dangerous! If this happened during surgery, it could cause delays or damage to the patient.

The notice explains that the cracking means any attempts to clean the device won’t be adequate as blood and bone debris can get into the cracks where it can’t be removed. Any irrigates used to wash the device may just loosen debris and inadvertently release it when the device is used on another patient.

All devices reportedly affected

The MHRA notes that “all lots of the DePuy Synthes Impactors for PFNA Blade (P/N 03.010.410) are affected” as part of the recall. The medical device alert requires staff who use these devices to:

What happens if you have suffered an infection?

If you’ve had an operation and you suspect an infection injury through contamination, you should ask for this to be investigated. As a patient, you have a right to expect the use of clean and sterile equipment when being operated on. As seen in the Dr D’Mello dental instruments contamination fiasco, thousands were put at risk of contracting Hepatitis B, Hepatitis C and HIV when it was discovered he wasn’t following appropriate NHS infection control procedures.

If you’ve had an operation where the device may have been used, we’d recommend asking the hospital to investigate this if you’ve suffered an infection.