Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.Device product code: htx.
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Event Description
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While using the rongeur to pull disc material from the interstitial space, the tip of the jaw broke off and fell into the surgical site.The piece was successfully retrieved leading to a delay of less than 30 minutes.
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Manufacturer Narrative
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No patient/user injury or adverse event associated with this report.The returned rongeur was evaluated.The jaw was confirmed to have broken off.A review of the manufacturing records did not identify any issues which would have contributed to this event.The cause of this event cannot be conclusively determined.
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Search Alerts/Recalls
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