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 available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Part # 04.168.280s, lot # 452p939, manufacturing site: grenchen, release to warehouse date: 28.October.2021, expiry date: 01 october 2031.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 japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent orif surgery for a femoral neck fracture with fns implants.After surgery on (b)(6) 2022, the patient complained of pain, and subtrochanteric fracture of femur at the area where the locking screw of fns was inserted was confirmed.On (b)(6) 2022, a revision surgery was performed.In the revision surgery, fns implants were removed and replaced with femoral recon nail implants to fix the fracture site.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for a bolt for femoral neck system 80mm length-sterile.This is report 2 of 4 for (b)(4).
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