SYNTHES GMBH ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 04.168.485S |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Reporter occupation: reporter is a j&j employee.Device evaluated by mfr: 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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Event Description
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It was reported, that on (b)(6) 2022, the patient underwent open reduction and internal fixation (orif) surgery with femoral neck system (fns) implants for femoral neck fracture.Although the surgeon acknowledged that the patient¿s bone quality was fragile, he chose to use fna implants to fix the fracture site.After surgery, the reduction position gradually collapsed, and cut-out occurred.The surgeon assumed that the cause of this event was the patient¿s bone quality.No further information is available.This report is for one (1) antirotscr f/fem neck syst f/construct l this is report 3 of 4 for complaint (b)(4).
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Manufacturer Narrative
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Part #: 04.168.485s.Lot #: 175p508.Manufacturing site: jabil grenchen.Release to warehouse date: 26, may 2021.Expiry date: 01, may 2031.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 if information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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