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An event regarding an alleged broken and warped hinge involving a custom proximal tibia was reported.
The event was confirmed.
Method and results product evaluation and results: not performed as no items were returned.
Medical records received and evaluation: x-ray review- based on a review of the provided information, the reported fracture of the hinge has been confirmed.
The reported fracture could be as a result of patient factors such as overweight or activity levels, not necessarily related to the design and manufacture of the device itself.
Product history review: review of the device history record indicate one device was manufactured and accepted into final stock on 31 oct 1989, with no reported discrepancies.
Complaint history review: based on the device identification the complaint databases were reviewed from 2012 to present for similar reported events regarding tibial hinge crack/fracture.
There have been 3 other events.
Conclusions: it is reported that during a procedure to rebush a custom proximal tibia, that had been implanted for 28 years, it was noted that the hinge was broken and warped.
The exact cause of the event could not be determined because further information such as device return, patient history and follow up notes are needed to complete the investigation for determining root cause.
No further investigation for this event is possible at this time as no devices and insufficient information was received by siw.
If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.
Siw will continue to monitor for trends.
Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.
Please note: the reported device is similar to a patient specific proximal tibia device approved for compassionate use in the united states.
Device not returned.
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