ARTHREX, INC. BONE CUTTER,5.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Model Number BONE CUTTER,5.0MM X 13CM |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/19/2022 |
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 an autocart ankle arthroscopy surgery the device was used for a few seconds on the bone cartilage and then started right away to show some very small metal particles to come off.Metal particles remained inside the patient.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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Manufacturer Narrative
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Complaint is confirmed.One unpackaged ar-8500bc batch number 10872333 was received for investigation.Visual inspection identified heavy, horizontal scratches lines along the outer diameter of the inner tube bone cutter.After removing the outer tube, more horizontal scratches were observed along the tip.Visual signs of wear were also observed proximal to the hub and along the inner and outer tube shaft.Tissue was found to be lodged in the inner and outer tubes.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces applied during use.
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Manufacturer Narrative
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Complaint is confirmed.One unpackaged ar-8500bc batch number 10872333 was received for investigation.Visual inspection identified heavy, horizontal scratches lines along the outer diameter of the inner tube bone cutter.After removing the outer tube, more horizontal scratches were observed along the tip.Visual signs of wear were also observed proximal to the hub and along the inner and outer tube shaft.Tissue was found to be lodged in the inner and outer tubes.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces applied during use.
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Search Alerts/Recalls
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