This report is for an unknown pfna end cap/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).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 that on (b)(6) 2020, a patient underwent the proximal femoral nail antirotation (pfna) system removal procedure due to pain, after consolidation in a patient.Initially the patient was implanted with a proximal femoral nail antirotation system on an unknown date.This report captures the reported event of hardware removal due to pain, while related complaint (b)(4) captures the reported intraop issue that occurred during hardware removal.Concomitant device reported: pfna nail (part # unknown, lot # unknown, quantity 1); pfna blade(part # unknown, lot # unknown, quantity 1); locking screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown pfna end cap.This is report 3 of 4 for complaint (b)(4).
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