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.Event occurred at an unknown date between (b)(6) 2021 and (b)(6) 2022.This report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 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 (b)(6) reports an event as follows: it was reported that in around (b)(6) 2021, the patient underwent orif surgery for trochanteric fracture of femur.The surgery was completed successfully with no surgical delay.At an unknown point after surgery non-union occurred, which stressed the nail in question causing it to break at its bump-cut area of the blade-insertion hole.On (b)(6) 2022, tfna implants are to be extracted and a revision surgery will be performed via bha.This report is for an unk - nail: tfna.This is report 1 of 1 for (b)(4).
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