Product complaint # (b)(4).Additional product code: hwc.Occupation: reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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, the patient had a nonunion, lateral fracture.Va-lcp anterior plate was used.There was a reoperation due to dps implants and hardware removal, patient could feel implant.Union was achieved after 6 weeks.Patient outcome is unknown.No further information is available.This complaint involves 1 (one) device.This report is for (1)1.5mm drill bit/qc/110mm.This report is 1 of 1 for (b)(4).
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