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This report is submitted regarding injury to (b)(6).Ms.(b)(6) had right total hip replacement surgery during which, it is believed, bair hugger was used, causing contamination of the wound and leading to infection.She subsequently experienced persistent pain and symptoms related to a deep infection in her hip and was forced to undergo a 2-stage revision.She suffers ongoing injuries.Ms.(b)(6), her 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 her surgery.The mfr of bair hugger faw 3m corporation, was notified in writing of the injury by litigation ((b)(6)).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 telephone calls or other verbal communication, fax transmissiions, written correspondence, sales rep reports, service rep reports, scientific articles (literature), internal analyses, and legal documents." 3m has failed to report this injury within the mandatory 30 days.Ms.(b)(6) and her lawyers assert that the approx 1000 watts of waste heat from bair hugger faw escapes from below the surgical drapes near the floor.From there, 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, easily penetrating operating room ventilation airflow and ending up in the sterile surgical field.This phenomenon has been proved in at least six (6) studies published in top-tier, peer-reviewed medical journals.Many other studies have shown that the concentration of airborne contaminants 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 the 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 pji's after total joint replacement surgery.In contrast, there are no outcome studies showing that bair hugger faw is safe in implant surgery.In a separate issue, ms.(b)(6) asserts that 3m has willfully violated the terms of the bair hugger 510 (k).When 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 top-tier, peer-reviewed medical journals.Further, the high-velocity airflow over the bacterial colonies has been shown to aerosolize bacteria out of the hose and into the operating room air.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 the contamination of the operating room with the bacteria growing inside the blower and hose.Given the catastrophic nature of pji's, 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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