The device was returned for investigation.No ncmrs were associated with this lot or failure reported.Without the ln of the screw, a review of the dhr and ncmr database could not be completed.The 5.5x45mm modular bone screw and top loading body (pn: 44-5545 and 36-2101, ln: unk and o65) were returned for investigation.Information provided stated that there was an incident involving a firebird screw from a surgery done in february.Inspection of the returned product confirmed the screw was broken and the head of the screw was jammed in the top loading body.Numerous attempts were made to gather necessary additional information without success.Without additional radiographic images, it was not possible to assess the potential role of surgical technique or patient selection.Based on the limited information provided, it was not possible to determine the cause of this reported failure.This is the 1st occurrence of this reported failure mode for pn: 44-5545 in the past 2 years out of approximately (b)(4) units sold.The estimated occurrence rate is (b)(4), which corresponds to a level 2 (remote).This is the 1st occurrence of this reported failure mode for pn: 36-2101 in the past 2 years out of approximately (b)(4) units sold.The estimated occurrence rate is (b)(4), which corresponds to a level 1 (improbable).
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