(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
Evaluation summary: visual and dimensional inspections were performed on the returned device.
The reported separation was confirmed.
The reported difficulty positioning the device could not be replicated in a testing environment due to the condition of the returned device.
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
Additionally, a review of the complaint history identified no other incidents from this lot.
The investigation determined the reported shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the device could not be determined.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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