Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.There were no immediately observable defects to the screw.Close examination of the saddle while handling the screw shank found that the saddle shifted a couple of millimeters while moving the shank.The saddle is intended to stay in a nearly fixed position and not have this amount of play to it.The saddle was also noted to twist slightly clockwise and counter clockwise when the saddle was pushed in the corresponding direction.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the saddle being forced loose into the tulip head cannot be determined from the sample and the information provided.A potential root cause may be excessive force placed on the screw during tightening.This may have occurred if high amounts of stress were placed on the saddle, especially at an extreme angle in relation to the adjacent components of the screw.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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