Model Number 121135 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that the instrument was being used on the field in the patient's right leg during insertion of an intramedullary nail (femur).A piece of the tip was found in the leg while using c-arm during procedure.The piece was removed from the patient and placed in a specimen cup with lid.The instrument and specimen cup were immediately removed from the sterile field and given to circulator.An x-ray was taken to confirm that no retained objects remained.There was no consequence to patient as a result of the product problem and no procedural delay occurred.
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Manufacturer Narrative
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The instrument was not returned and it was not possible to determine the manufacturing lot number.However, on the basis of the available information it was established that the device was manufactured in the second quarter of 2015.The device history records of all batches of the device that were manufactured during this period were reviewed.No problems were found.The device's complaint history was reviewed for the period from 2015 through 2022 and no problems were found.The investigation has been closed.Should additional information become known, the complaint will be reopened.
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Search Alerts/Recalls
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