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 date of event: only the event year is known.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) hospital.The initial reporter is a j&j employee.Part #: 04.168.480s.Lot #: 333p963.Manufacturing site: (b)(4).Release to warehouse date: 20, august 2021.Expiry date: 01, august 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.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 japan as follows: it was reported that on (b)(6) 2022, the patient underwent an unknown surgery with the fns for a femoral neck fracture.The surgery was completed successfully without any surgical delay.However, cut-out of the bolt was suspected immediately after the surgery, and the surgeon had been following up with the patient.Postoperative x-ray showed the implant sliding and 1 to 2 mm cut-out of the bolt.A revision surgery is undecided.No further information is available.This report involves one antirotation screw for femoral neck sys 80mm length - steril.This is report 2 of 4 for (b)(4).
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