A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.The x-ray demonstrates that the ratchet mechanism has collapsed the best assumption in these past similar cases was that tissue growth into the ratchet mechanism was the reason for the problem.Since the implant is not available for evaluation full investigation and conclusion cannot be determined at this stage.Risk assessment and corrective action: the risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.1and 1.6).This event does not increase the probability rating.The company has implemented corrective action resulting in an updated design of the mid-c 95 to increase the strength of the ratchet spring (eco13 dms-1213) the incident rate of ratchet malfunction following this mitigation stands at (b)(4) (including the present case).In addition, the company implemented an additional design change of the stopper pin (eco-59).No ratchet failures were reported following this mitigation.The current incident rate of ratchet malfunction is in line with the rate of device-related adverse events ( 7.99% vs 15.5% reported in the literature.See cer dms 727 rev r4).
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