Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales consultant.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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It was reported that on an unknown date, one (1) wire guide 12/3.2mm for suprapatellar, and one (1) wire guide 14.5/3.2 for suprapatellar were worn from usage, and not up to hospital standards.There were no patient, and surgical involvement. this report is for one (1) wire guide/2 holes 12.0/3.2mm for suprapatellar this is report 1 of 2 for (b)(4).
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