It was reported that the retention clip was visibly shrunken after being autoclaved.Rep had a backup ring from a different lot number so when it was seen that clip had shrank, it was immediately removed from the case.Following the case, the rep trialed the clip in a bipolar head and confirmed that it did allow the 28 head to fall out.Tolerances are not nearly tight enough for the clip to do its job.This was the 3rd time with the same lot number, same hospital and same surgeon that this clip has shrank after being sterilized.Rep is currently borrowing another clip from a different lot number in order to be able to complete cases.No pieces broke off in patient, all pieces were recovered.Surgery time was not extended due to any complications from depuy products.
|
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
|