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Model Number PUNCH, STD STR TP, 2.75 STR, W/FLUSHPORT |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The related condition is typically caused by applying excessive force while attempting to cut tissue and/or an excessive amount of tissue at one time.The results of the investigation of this complaint did not change the harm identified during intake.
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Event Description
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It was reported that during meniscus surgery the device does not bite anymore, the pin is broken.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
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Search Alerts/Recalls
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