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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Limb Fracture (4518)
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Event Date 12/01/2022 |
Event Type
malfunction
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Event Description
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On january 13th 2023, microaire was notified via email with the uf/importer report # (b)(4) that a male who fractured his right wrist playing basketball in [redacted date].He underwent open reduction internal fixation on [redacted date], and revision surgery on [redacted date].His initial surgery was not with hss however his revision surgery with placement of a bone screw and kwire hardware took place on [redactive date] at hss nyc with dr.[redacted name].On [redacted date] the patient presented to hss, where dr.[redacted name] performed removal of right wrist hardware.Prior to this procedure, he noted that the pin had migrated slightly necessitating operative removal under anesthesia.The pin was removed successfully, however there were retained fragments identified by fluoroscopy following pin removal.Two minute fragments were left in place by dr.[redacted name] after extensive search and removal attempt rather than sustaining the risk of wider open operative dissection.
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Manufacturer Narrative
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As the product associated with the reported even was not returned, it was not possible to conduct an evaluation of the device.Since the part number and or lot # of the device was not provided, it was not possible to conduct a device history review.A review of the complaint history for microaire k-wires has revealed that this product line is performing as expected, with regard to the reported incident.With the information provided, it was not possible to identify a root cause; however potential user-related causes of the reported incident include off-axis drilling and improper selection of device.If additional information becomes available, this investigation will be re-opened.
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Search Alerts/Recalls
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