SMITH & NEPHEW, INC. R3 STRAIGHT SHELL IMPACTOR; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
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Catalog Number 71364450 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2019 |
Event Type
malfunction
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Event Description
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It was reported that the during surgery the instrument broke while impacting the r3 shell into acetabulum.Surgeon did not realize about the fail until he was done.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The weld on the bottom x-bar holder clamp fractured, making the device inoperable.The device was manufactured in 2015 and exhibits signs of extensive wear/usage.The fracture was likely due fatigue loading of the weld joint caused by repeated impacts.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.
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