SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE RT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71360090 |
Device Problem
Misassembled (1398)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that broach handles separated from the broach when backing out from femur.No delay, backup available.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual / functional inspection of the returned device could not confirm the stated failure mode.The device functions as intended with a mating part.The device was manufactured in 2014 and exhibits signs of extensive wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Credit will be issued for the device.
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