Model Number N/A |
Device Problems
Break (1069); Fracture (1260); Off-Label Use (1494)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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.Report two of four for the same event, see also 0001032347-2015-00420 (-1), 0001032347-2015-00475 and 0001032347-2015-00476.
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Event Description
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The facility reported they would like to return seven 301 elevators that are broken.No dates, surgery details, or patient information was able to be provided.The facility confirmed there were no adverse events.
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Manufacturer Narrative
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Upon visual inspection, the complaint has been confirmed that the tip is broken.The device history record was reviewed and no non-conformance was found for this lot.There are no indication of manufacturing defects.The ifu for this part (instructions for use) states that "the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip." the most likely underlying cause is excessive force.Supplemental report two of four from the same customer, reference 0001032347-2015-00420-2, 0001032347-2015-00475-1 and 0001032347-2015-00476-1.
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Search Alerts/Recalls
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