Model Number ROB10011 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during set up of cori assisted ukr, it was noticed that one ri bone pine was bent.There was no patient involvement.
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Event Description
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It was reported that, during set up of cori assisted ukr, it was noticed that one ri bone pine was bent.Procedure was performed, without any delay, with a back-up device instead.There was no patient involvement.
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Manufacturer Narrative
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Corrected data: b5.
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Manufacturer Narrative
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H3, h6: the ri bone pins 4 mm x 152 mm qty: 2, part number rob10011, intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with product mishandling during insertion or removal.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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