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This report is submitted regarding injury to (b)(6).On (b)(6) 2013, the bair hugger was used on mr.(b)(6) during his right knee replacement surgery.Because the bair hugger was used, contaminants were introduced into the open surgical wound, resulting in an infection.Mr.(b)(6) needed two add'l surgeries within nine months of the original implant surgery.The first surgical procedure included removal of the implant, cleaning of the infected area and placement of a temporary antibiotic spacer.Months later, the second procedure included the removal of the antibiotic spacer and placement of another permanent knee implant.He continues to suffer impaired mobility and pain in the knee.Mr.(b)(6), his experts and lawyers believe that the infection was caused by contamination of the sterile surgical field by the waste heat of the bair hugger forced-air warming system ("faw") used during his surgery.3m corporation, the mfr of bair hugger faw was notified in writing of the injury by litigation ((b)(6) filed in the district of (b)(6) on august 19, 2015).Fda guidance dated july 9, 2013 provides that such legal documents constitute a "complaint" requiring the mfr to report to the fda, as follows: "2.11 where will device-related complaints come from? you may receive complaint info from many different sources, including legal documents." 3m has failed to report this injury within the mandatory 30 days.Mr (b)(6) and his lawyers assert that approx 1000 watts of waste heat from bair hugger faw escapes from below the surgical drapes near the floor.It warms the contaminated air normally resident near the floor and forms into convection currents of rising contaminated warm air.The warm air rises alongside the surgical table, penetrating operating room ventilation airflow and ending up in the sterile surgical field.This phenomenon has been proven in at least six studies published in top-tier, peer-reviewed medical journals.Many other studies have shown that the concentration of airborne contaminant above the wound positively correlates with the concentration of contaminants in the wound, and also positively correlates with the periprosthetic joint infection ("pji") rate.This leads to the inevitable conclusion that waste heat from bair hugger faw must be increasing the risk of pji.At least one large outcome study has positively linked this rising waste faw heat to the majority of pjis after total joint replacement surgery.There are no outcome studies showing that bair hugger faw is safe in implant surgery.In a separate issue.Mr.(b)(6) asserts that 3m has willfully violated the terms of the bair hugger 510 (k).When the 510(k) #12345676 was filed in 2004, the mfr committed to a "hepa" quality inlet filter (99.97% or greater filtration efficiency).In fact, the inlet filter of the bair hugger model 505 blower was never hepa and has now been reduced to 62% efficiency without notifying the fda.The result of the poor inlet filtration is that the internal airflow pathways of nearly all bair hugger blowers and hoses are contaminated with growing bacterial colonies.This has been shown in three studies published in peer-reviewed medical journals.The high-velocity airflow over the bacterial colonies has been shown to aerosolize bacteria out of the hose and into the operating room.Since it is impossible to disinfect the internal airflow pathway of the bair hugger 505 blower, a hepa filter should be added to the outlet hose of these blowers to prevent operating room contamination from the bacteria growing inside the blower and hose.Given the catastrophic nature of pjis, it is only prudent for the fda to err on the side of caution.Considering that there are several air-free and waste heat-free pt warming devices on the market today, any product that increases the risk of a pji should not be allowed in orthopedic surgery.
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