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Catalog Number AR-1588T |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Tissue Damage (2104)
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Event Date 06/26/2017 |
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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.This is the first complaint of this type for this part/lot combination.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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Event Description
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It was reported that during an acl reconstruction procedure, after drilling the femoral tunnel with the 4mm spade tip guide pin (ar-1595t), the surgeon passed the acl tightrope (lot: 10062782, line 198547) while retrieving the white tension sutures.After the button was flipped, the surgeon was unable to tension the graft into the socket at all.After numerous attempts he cut out the acl tightrope and used another of the same with no complications.An unplanned incision was made on the femoral side to cut out the acl tightrope.The tightrope was cut up and completely removed from the patient and discarded by nursing staff after the case was completed.
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Search Alerts/Recalls
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