STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE OFFSET RASP HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 1020-1400 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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While doing a saw bone demo with exeter, the broach handles disengaged from the broach.
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Event Description
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While doing a saw bone demo with exeter, the broach handles disengaged from the broach.
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Manufacturer Narrative
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An event regarding assembly issue involving an accolade handle was reported.Review of the product history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusion: the device was discovered during a demonstration.A functional inspection was performed on the returned device and found it be fully functional.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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