Catalog Number 261221 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
Brain Injury (2219)
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Event Date 02/23/2021 |
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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A facility reported that during drilling the perforator failed to stop resulting in "plunging of the drill, durotomy and likely vessel injury".The injury was treated with hemostasis.The event led to 30 minutes surgical delay.A replacement device was not required as the burr hole was already made.
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Manufacturer Narrative
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Dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.The perforator was returned for evaluation: failure analysis: the perforator unit was inspected using the unaided eye.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.Although the complaint was not confirmed, root cause was investigated and potential causes of failure include: perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, or user misuse.
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Event Description
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N/a.
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Manufacturer Narrative
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Perforator was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Potential causes of failure include: perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, or user misuses device.
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Search Alerts/Recalls
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