Catalog Number 623-00-32D |
Device Problems
Material Distortion (2977); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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During trident surgery, scratch was noted to trident 0 deg x3 insert 32mm head.The insert head was exchanged with another new one.
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Manufacturer Narrative
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An event regarding damage involving a trident liner was reported.The event was confirmed by visual inspection.Conclusions: it was reported that during surgery scratch was observed on the trident insert.Visual of the returned device noted that the device was returned in used condition.Device was observed to be damaged on distal rim.Scratch and small dents were observed on the distal rim.A review of the device by the material analysis engineer indicated that damage observed on distal rim of insert.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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During trident surgery, scratch was noted to trident 0 deg x3 insert 32mm head.The insert head was exchanged with another new one.
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Search Alerts/Recalls
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