SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71365705 |
Device Problem
Device Fell (4014)
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Patient Problem
Injury (2348)
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Event Date 01/31/2019 |
Event Type
Injury
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Event Description
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It was reported that during surgery the screw holding the stem on the handle broke in the implant, could not be removed so it stayed in the stem inside the patient.No delay was reported and no backup device was available.
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Manufacturer Narrative
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The associated complaint device was not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.
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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, rendering the device inoperable.The tip was not returned.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.The fracture is most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts occurring while the inserter is not fully captured in the driver hole platform of the stem.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.The medical investigation concluded that, based on the limited information provided, the root cause of the reported broken threaded tip cannot be determined.The 17-4ph is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.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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