WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; WIRE, SURGICAL
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Non-union Bone Fracture (2369); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown cable/wire: orthopaedic cable/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.
|
|
Event Description
|
It was reported that on (b)(6) 2019, one (1) trochanteric femoral nail, one (1) helical blade, one (1) unknown locking screw, and one (1) unknown cable wire were removed due to nonunion.The patient had a tumor in the proximal femur.The femur was resected and a total hip was done.All hardware came out successfully.It is unknown if there was surgical delay.Procedure outcome was unknown.There was no patient consequence.This report is for one (1) unknown cable/wire: orthopaedic cable this is report 4 of 4 for complaint (b)(4).
|
|
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: h3, h4, h6 investigation summary.Complaint is confirmed as we are able to confirm complaint description (nonunion visible) based on the received pictures.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 (information or/and material), 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.
|
|
Search Alerts/Recalls
|
|
|