MEDTRONIC XOMED INC. PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
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Model Number 1150001 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The product is shipped in a ridged capsule which protects the device during shipping.There were no signs that the device was closed in the lid of the capsule.Visually, the flex h/a had become detached from the titanium bell which would have resulted in the reported event.Adhesive is required to bind the two components together and when viewed under magnification, a residue consistent with adhesive was present in the mounting area which likely indicates it was assembled properly.The portion that had become detached was installed on the shaft indicating handling.The flex h/a was removed from the shaft for further analysis.The overall length of the head shaft assembly should be approximately 0.400¿ and the actual measurement was 0.072¿.The shaft configuration is consistent with being cut off.The cam head was bent and contained tool marks.The flex h/a is a porous material measuring approximately 0.045¿ in diameter which makes it vulnerable to mishandling.There was no allegation of a defect prior to handling.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates the device was modified and the damage occurred while handling.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare provider (hcp) reported that during a procedure for a cholesteatoma resection, artificial ossicular implantation and tympanoplasty, the artificial ossicular implant was broken during the tympanic portion of the surgery.The surgeon removed the broken device and ¿switched to the autologous ossicle for hearing reconstruction and completed the operation.¿ the patient was alive with no injury.On follow up, it was confirmed there was no procedure delay.There was no patient impact.
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