The complaint description states that the implant locking plate has snapped off.The device associated to the complaint was returned for analysis.The visual analysis shows the break of the 4 screws of the lower plate.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product code and lot combination.Previous complaints were received for a similar incident ((b)(4) and (b)(4)).The analysis performed by r&d concluded that there is a contradiction between the drawing for the screw ((b)(4)) and (b)(4) (a standard for socket countersunk screws), regarding the hexagon depth.This contradiction, allows much less material in the cross section of the screw where the fracture occurs.The 0.4mm deviation in depth between the specifications decrease the wall thickness by 25%.Furthermore, the risk management ((b)(4)) was reviewed and it did not include the failure mode identified in this complaint.The complaints were reviewed by a medical safety officer and it was concluded that there was no patient harm associated with the failure mode and the occurrence was remote.Given the low level of severity and occurrence of the failure mode no immediate actions were required and all product could be dispositioned ¿use as is¿.Based on the information received and the investigation performed, the root cause of the incident is related to product design.The discrepancy on the drawing between the standard quoted and dimensions stated will be amended and this failure mode will be included in the product risk management.These changes will be implemented through a change order.A change assessment has been created for these changes ((b)(4)).Depuy 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.
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