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Model Number 7205306 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Event Description
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During a shoulder scope procedure (date unknown), using a full radius bl 4.5mm, dspl., ep-1, it was reported that the blade shed into the joint.The surgeon removed most of the debris, but was unable to remove all of the pieces.There were no reports of patient injuries or complications.
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Manufacturer Narrative
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Customer indicated that there is no product/device to be returned for investigation analysis.(b)(4).
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Manufacturer Narrative
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Evaluation of the device was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.
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Search Alerts/Recalls
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