Additional product code: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.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 synthes reports an event in (b)(6) as follows: it was reported, by a disappointed and frustrated surgeon that three of his patients, plus two patients of his colleague surgeon (for a total of five patients) who have experienced a 4.5mm variable angle lcp (va-lcp) curved condylar bridge plate construct failure after very short time and had to go for a post-op surgery in the management of highly comminuted distal femoral fracture.I was only told of these five fractures today but these construct failures have happened in last few months.Surgeon has promised to supply more information shortly and suspect that the combi hole four column threads maybe the source of a stress riser, at screw/plate junction failure.Procedure was completed successfully without any delay.This report is for one (1) 4.5mm va-lcp curved condylar plate/18 hole/370mm/right.This is report 1 of 2 for (b)(4).
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