Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states but is similar to device marketed in the usa.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2020, the patient underwent for reduction of periprosthetic fracture in the left femur.During the surgery it was noticed that there was no instrument box corresponding to the cable and tension system.The surgeon used alternate instruments used for the proposed fixation of the proximal femur plate.The surgeon reduces the fracture and tension of the system, then fix the cable system using institutional material.The procedure was completed successfully without delay.The patient outcome was unknown.Concomitant device reported: unknown proximal femur plate (part # unknown, lot # unknown, quantity unknown).This is report 01 of 03 of (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6- 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 history lot manufacturing location: supplier rti surgical / inspected, packaged and released by: monument release to warehouse date: 10-oct-2019 part number: 298.801.01, 1.7mm cable with crimp 750mm lot number: p343573 this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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