DePuy Synthes—Flex Arm Instruments: Quick Connect Feature May Fail
April 11, 2018 | Risk Management News
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In a March 21, 2018, Urgent Product Recall letter submitted by an ECRI Institute member hospital and a March 21, 2018, Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), DePuy Synthes states that it has received complaints of the quick connect feature of the above Flex Arms failing to secure the connection with the Flex Arm Adaptors, Insight Retractors, or other mating parts. If the Flex Arm is unable to connect to a retractor or adaptor during surgery, surgical delay may occur while an alternative instrument to complete the surgery is obtained. The manufacturer has not confirmed the...