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Catalog Number AR-13991N |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/07/2015 |
Event Type
Injury
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Manufacturer Narrative
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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 received and an evaluation was conducted.Device history record review revealed nothing relevant to this event.Complaint was confirmed.The device has a broken needle point and a buckled needle.The mating part (instrument) used in the event was not returned.The typical cause for this type of event is 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.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 a rotator cuff repair, two scorpion needles, ar-13991n broke.Both breakages occurred during the suture passing of the open rtc procedure.After each breakage a c-arm was brought into the room to search for the broken tip.The first needle broke and the c-arm was used to locate and retrieve the tip.The procedure continued and the next needle broke.The c-arm was used but the tip was not located or retrieved.No additional incisions were made.
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Search Alerts/Recalls
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