|
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
Patient Problems
Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Pma/510k: this report is for an unk - nails: tfna/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
|
|
Event Description
|
It was reported that on an unknown date the patient underwent a removal surgery putting a total hip procedure using a tfna with a spiral blade with light screw.The surgical delay is unknown.The patient outcome is unknown.This complaint involves five (5) devices.This report is for (1) unk - nails: tfna.This report is 1 of 5 for (b)(4).
|
|
Event Description
|
It was reported that the revision surgery was performed due to proximal femur non-union.It was confirmed that the screws broke post operatively and was found on x-rays prior to the removal procedure.The broken fragments of the screws remained in the patient.The removal of tfna with lag screw and traumacem was done and patient was revised with a total hip.The revision surgery was completed successfully.
|
|
Manufacturer Narrative
|
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: h6: 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.B1, b5, h1: the retraction mw was inadvertently submitted on follow-up-1 report.This device tfna nail is still reportable to fda as patient developed proximal femur non-union postoperatively.
|
|
Search Alerts/Recalls
|
|
|