ARTHREX, INC. Ø7X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Model Number Ø7X 20MM BC IF SCRW, VENTED |
Device Problems
Break (1069); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
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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It was reported that during a posterolateral corner reconstruction surgery the screw was not fitting on the screw driver properly which lead to breaking the screw during insertion.The broken piece was retrieved from patient.Then they opened another one same screw size but different lot number the same problem happened.The screw is not fitting on the screw driver and then opened a third one, it fit correctly and was used without any problems.There was no harm for patient, operator or third party.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.
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Search Alerts/Recalls
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