Model Number 1883672HS |
Device Problems
Break (1069); Material Fragmentation (1261)
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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 Date 09/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Product evaluation: analysis results not available; the devices were not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that "two drills broke themselves in the nose during their use in the course of surgical operation." there was no reported patient impact.
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Manufacturer Narrative
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Event Description
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Additional information received confirming that during a frontal sinus procedure, "as the burs were broken in the nose, some fragment were detached but the surgeon didn¿t have problems to pick it up.The surgeon has used instruments to retrieve the fragment ¿ no fragments remained in the patient.".
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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We originally reported 2 burs on mdr 1045254-2016-00374.This report is being submitted for the product analysis of the first bur, a subsequent supplemental report will be filed for the product analysis of the second bur.Product evaluation: the hi speed diamond 70deg bur, part number 1883672hs, from lot number 0209955643, was received for analysis.There was a residue consistent with biological contaminants on the devices.Biological contaminants were found to be compacted in the diamond grit which likely resulted in the customer applying excess pressure to the bur in an attempt to maintain performance.When viewed under magnification there was evidence of aggressive use; gouging of the outside diameter of the inner shaft just proximal to the tip; and corresponding damage to the outer tube support area (including a thinning of the wall).Visually, the inner assembly tip broke off at the spiral wrap which would have resulted in the reported event.The section measured 0.50¿ from the tip to the break point.The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break is consistent with excessive torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information found during the product analysis: the spiral wrap stretched and the tip detached from the first bur; the spiral wrap stretched but remained intact for the second bur.
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Search Alerts/Recalls
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