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Model Number 311720115E |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/02/2019 |
Event Type
malfunction
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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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Event Description
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A health care provider (hcp) reported that during a mastoidectomy, the distal portion of the curved bur (head of the bur) broke at the beginning of its use, all fragments were collected.There was a procedure delay.There was no patient impact.
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Manufacturer Narrative
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Analysis found visually, the distal cutting tip broke off which would have resulted in the reported event.The portion that became detached measured 0.13¿.The break location corresponds to the distal end of the outer tube after assembly.The configuration of the break was consistent with shear or bending stresses.The nominal shaft diameter at the break is 0.020¿ and should not be subjected to bending or prying.The cutting flutes were rough and worn distal to the center line of the head.The remainder of the inner shaft assembly was pulled out of the outer assembly and bent.The proximal tang which locks into the handpiece (when properly loaded) was rough and worn indicating at some point the bur was improperly engaged with the handpiece drive mechanism.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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