Catalog Number 261221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Perforation (2001)
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Event Date 03/04/2021 |
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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1 of 4 reports: different patients, same failure.Other mfg report numbers: 3014334038-2021-00066, 3014334038-2021-00067, 3014334038-2021-00068.A facility reported a perforator failed to disengage and stopped spinning when it reached the inner table of the skull.The perforator contacted the dura.Medtronic was the manufacturer of the electric drill.The perforator clicked into place in the drill.The surgeon had to change to perform a craniotomy and remove a larger bone flap incorporating the perforator site.The patient tolerated the procedure.Three similar incidents happened on 3 different occasions, within a 3-week period.Each patient was treated the same, since it was the same three surgeons working together; the bone flap was expanded with a craniotomy and dura was sutured.
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Manufacturer Narrative
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The perforator was returned for evaluation: dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Label was partially worn and could not be read.The unit was lightly soiled from surgery.No other anomalies were observed.Ifu testing was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review and trending were performed as part of the evaluation.Product was received for analysis and the investigation could not confirm the complaint.
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Event Description
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N/a.
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Search Alerts/Recalls
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