If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.A device history record (dhr) review was conducted: part # (b)(4), lot # 79p5095, manufacturing site: (b)(4), release to warehouse date: (b)(6) 2020, expiry date: (b)(6) 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery with the proximal femoral nail antirotation (pfna) system.The surgery was completed successfully without any surgical delay.The patient had been doing well since the surgery; however, patient fell down on (b)(6) 2022.The patient went to the hospital and complained of pain on (b)(6) 2022.It was confirmed that proximal cut-out and a secondary fracture at the distal nail occurred.The revision surgery was performed on (b)(6) 2022.No further information is available.This report is for one (1) pfna-ii blade l80 tan.This is report 1 of 2 for complaint (b)(4).
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