SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
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Catalog Number 71365705 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery the inserter tip broke off in stem while impacting the implant.No delay nor injury reported.A s&n backup was available.No pieces fell inside the patient, but the broken tip was left inside the stem.
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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 tip of the threaded end of the device fractured off and was not returned.The device was manufactured in 2008 and exhibits signs of extensive wear / usage.This failure likely occurred from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.The medical investigation concluded that, based solely on the product evaluation, the root cause of the inserter tip breakage was due to age related wear.It is unclear if the ifu were adhered to; however, it was noted in the ifu as a potential complication.The inserter tip is comprised of a non-implantable alloy and it recommends no patient contact or only short-term contact with tissue and/ or bone for less than 24 hours.Since it was indicated the inserter tip remained inside the stem, which was embedded in the bone, migration/micromotion is unlikely.The patient impact beyond the local irritation/discomfort and probable mri restrictions cannot be determined.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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.
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