Catalog Number 7208000000 |
Device Problems
Vibration (1674); Electrical Power Problem (2925); Device Handling Problem (3265)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 02/27/2019 |
Event Type
Injury
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Event Description
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It was reported by the user facility during a hip prosthesis that the motor suddenly stopped while cutting.It was further reported that the patient's bone broke during the procedure.The procedure was then completed successfully after the bone was repaired.No additional adverse consequences were associated with this event.
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Manufacturer Narrative
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Upon evaluation by a manufacturer technician it was found during device evaluation that the sag saw head components were worn.A worn drive link on blade mount base failure or worn bearings in the sag head assembly can affect device functionality and cause or contribute to the handpiece vibrating while cutting.A vibrating handpiece that also has functionality issues, such as a loss of function or intermittent function, could cause an event in which there could be a sudden motion causing the reported event; however, this was not confirmed.
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Event Description
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It was reported by the user facility during a hip prosthesis that the motor suddenly stopped while cutting.It was further reported that the patient's bone broke during the procedure.The procedure was then completed successfully after the bone was repaired.No additional adverse consequences were associated with this event.
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Search Alerts/Recalls
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