Model Number GB520R |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with gb520r - hi-line craniotome hdpc w/o duraguard.According to the complaint description, the steel ball fell off.When cleaning the milling cutter head, the medical staff of the disinfection center found that the steel ball in the bearing of the milling cutter handle fell off and the bearing inside the handle was damaged.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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