It was reported that the surgeon passed the needle through the cuff and upon retrieving the instrument, realized that the tip of the needle was missing.A mini x-ray machine was brought into the or for the shoulder.Upon reviewing results, the surgeon confirmed the needle tip was lodged in the tendon.The surgeon attempted to retrieve the broken tip but was unable to do so.Case: right rotator cuff repair.
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Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
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