Model Number FF856R |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
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 ff856r - caspar osteophyte ronghv-dty3mm180mm.According to the complaint description, the item is broken (incident).It occurred during a cervical procedure and there were no broken pieces.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Updated d4: lot number.Updated d9: date device returned to manufacturer.Updated h4: device manufacturing date.Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: products available for investigation in a decontaminated condition.Vigilance investigator carried out the pictorial documentation visually and microscopically.All three rongeurs are cracked on the joint of the jaw with the shaft.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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