This report is for unknown locking screws/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.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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Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, a humerus plating case was to take place with locking compression plates (lcp).It was discovered that the set only had one 24mm locking screw.The surgeon had to use cortical screws instead, compromising fixation of the fracture.Procedure was completed with an unknown delay.This report is for unknown locking screws.This is report 1 of 1 for (b)(4).
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