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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluated by mfr and manufacture date: sterile part 04.005.546s, lot 2l26334: supplier: früh verpackungstechnik ag.Release to warehouse date: november 05, 2018.Expiration date: november 01, 2028.Non-sterile part 04.005.546, lot 2l11113: release to warehouse date: october 30, 2018.Manufacturer: mezzovico.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the primary surgery with the expert a2fn for the segmental comminuted fracture of the diaphyseal femur.It was noted the fracture was an ao fracture classification :32c2.The surgery was completed successfully without any surgical delay.Although there were no problems with implant fixation, the patient¿s biological activation was weak and pseudoarthrosis occurred after the primary surgery.This complaint covers the post-operative pseudoarthrosis.This is related to (b)(4) which captures an issue during the revision procedure due to the pseudoarthrosis.This report is for a locking screw.This is report 4 of 6 for (b)(4).
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