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Model Number SCORPION-MULTIFIRE NEEDLE |
Device Problems
Difficult to Remove (1528); Component Missing (2306)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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The procedure the patient underwent was an arthroscopic acromial decompression and mini open supraspinatus repair.The surgeon implanted 2 x 4.75 (ar_2324pslc) swivelocks, 1 loaded with fibertape and 1 with tigertape, these anchors formed the medial row for the tendon repair.The surgeon passed 2 tape limbs and 2 suture limbs, when he went to pass another suture with the scorpion, he noticed the tip of the needle was missing.The wound was then washed out with irrigation fluid.The needle tip which measured approximately 3mm (the multifire scorpion needle was measured against a new needle) was not retrieved during the wound wash out.The surgeon completed the rotator cuff supraspinatus repair passing the remaining tapes and sutures with a new scorpion multifire needle.Prior to finishing the surgery the surgeon checked the joint space for the needle tip which could not be seen.
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Search Alerts/Recalls
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