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Model Number 014394 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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H10: internal complaint reference case (b)(4).
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Event Description
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It was reported that, on (b)(6) 2022, a patient underwent a left knee acl, allograft with posterolateral corner reconstruction and anterolateral ligament reconstruction.During the procedure, a nitinol wire was used to place a screw.A knee x-ray was obtained and identified a 3cm radiopaque linear metallic structure projecting over the posterior soft tissues of the knee.The object, retrieved at an unspecified date, was a piece of a nitinol wire retained in the patient's posterior knee.The patient status is unknown.
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Manufacturer Narrative
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H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H11: corrected data updated section g4.
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Search Alerts/Recalls
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