Model Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
Brain Injury (2219)
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Event Date 04/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported a disposable perforator (id 261221) did not disengage when penetrating the bone and perforated the dura.The manufacturer of the drill used with the perforator was pneumatic medtronic drill.The perforator clicked in place in the drill, and the recommended spring tests were being performed between each burr hole.The angle of approach was perpendicular as the ifu states and maintained with no rocking motion.There was constant downward pressure.The patient was fine without major issues resulting from this incident.
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Event Description
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N/a.
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Manufacturer Narrative
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The codman perforator (id (b)(4)) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection utilizing unaided eye was performed.The unit was lightly soiled with organic material but showed no other anomalies.A spring test was performed.Unit passed as designed with no issues.The functional test was performed: the unit successfully drilled 5 holes with no issues.Root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.
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Search Alerts/Recalls
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