(b)(4).One viper 5.5 ti 5x50mm cortical fix polyaxial screw was received by the customer quality unit for evaluation.Visual examination found that the polyaxial¿s tulip head inner cap had disassembled from its intended location.No damage was present on the polyaxial screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.As a result, it is suggested that unanticipated high amount of "forces" was placed on the tulip head resulting in the inner cap becoming disassembled from its intended location.It was noted that the threads on the polyaxial¿s tulip head had become torn.Noted damage suggests that its matting device was likely not properly seated and inadvertently cross threading occurred, resulting in the threads becoming torn.A device history record review did not identify any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the inner cap becoming rotated from its intended position and the tulip head threads becoming torn cannot be positively determined.However, noted damage suggests that unanticipated high amount of "forces" was placed on the tulip head resulting in the inner cap becoming disassembled from its intended location.Also, it is suggested that inadvertently cross threading occurred, resulting in the threads becoming torn.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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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