If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported by the sales representative that during a biceps tenodesis, his clever hook, left became bent when removed from the tray and his gryphon drill bit cracked at the tip when it was accidently dropped by the surgeon.The surgeon completed the procedure with another like device with no patient consequences or delay.The sales rep reported that the devices were over 2 years old and has seen heavy use.The customer already discarded the devices.
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