Catalog Number 261221 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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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 physician reported the perforator disassembled at the time of trepanning during a craniotomy procedure.It occurred during making the second burr hole at the tent.The procedure was completed with a replacement product.It is unknown the drill manufacturer, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.
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Manufacturer Narrative
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The perforator 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 - the perforator unit was inspected using the unaided eye.The unit was disassembled and had a worn "eo" label.The ultrasonic weld on the blue sleeve was visibly protruding and stuck out enough to catch sliding objects on the surface.The weld should be flush with the rest of the sleeve to hold the unit together.The "ifu" testing procedure was performed: the unit was tested as received with the parts put together but not re-sleeved (not re-welded); it passed the spring test as is designed.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to not perform as intended.While the unit did successfully drill 5 holes, it was unstable and shaking/wobbly while doing so.The complaint was confirmed in the complaint investigation.The failure analysis performed confirmed that the unit had a proud weld which likely caused the unit to fail during surgery.A corrective action was implemented to evaluate this failure.
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Search Alerts/Recalls
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