Catalog Number 8733-7183 |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a rongeur became bent over time.There was not a specific surgery or patient associated with this event.
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Manufacturer Narrative
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Additional information: lot number; conclusions - current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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Additional information: the returned rongeur was evaluated.The upper jaw was found to be bent so that it no longer aligns with the bottom jaw.The cause is likely attributed to large applied forces during multiple uses that eventually overcame the mechanical capabilities of the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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