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Model Number DRIVER SHAFT, T-15, MEDIUM |
Device Problems
Product Quality Problem (1506); Fitting Problem (2183); Material Twisted/Bent (2981)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the drive feature is twisted but it also broken and missing approximately.065 in.It is not stated if a torque indicating device, which is recommended to prevent damaging the device, was used.Likely causes of the event include continually applying torque when the implant is not moving; shallow driver engagement depth; prying/leveraging the device.
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Event Description
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It was reported that during shoulder prosthesis surgery the material is too soft and therefore it is twisted after a while of usage.The screwdriver does not fit into the screw and needs to be replaced.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.
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Search Alerts/Recalls
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