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Catalog Number AR-8400EX |
Device Problems
Difficult to Remove (1528); Metal Shedding Debris (1804)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.Device history record review revealed nothing relevant to this event.Complainant's event is typically caused by excessive bending forces applied to the device during use.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
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Event Description
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It was reported that during a case, the 4.0mm excalibur was producing metal shavings inside the patient's joint when it was activated.The majority of the shavings were retrieved with suction.The case was completed was completed with a 3.8mm excalibur.Follow-up investigation: a shaver with suction was used to try to remove the shavings but they were fine and adhered to tissue and cartilage, making them impossible to remove without doing collateral damage to the joint.
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Search Alerts/Recalls
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