WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Model Number 03.037.012 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that on (b)(6) 2021, during a trochanteric femoral nailing advanced (tfna) procedure intramedullary (im) nailing of femur, the set screw was not put down, and instead reversed until it bound itself against the connecting screw of the tfna insertion handle.Consequently, the surgeon planned to leave it as is, but when attempting to remove the connecting screw, it would not budge.As a result, the tfna screw was removed (no 5.0mm locking screw was used) and trochanteric femoral nailing advanced (tfna) nail (still attached to the insertion handle) was removed.Then a new nail was opened and attached to a tfna hybrid handle.Surgeon reinserted the nail and finished the procedure with no further problems.Now the old nail is stuck to the insertions handle for tfna.The procedure was successfully completed with thirty (30) minutes surgical delay reported.No patient consequence reported.This report is for one (1) complete radiolucent insertion handle.This is report 2 of 3 for complaint (b)(4).
|
|
Search Alerts/Recalls
|
|
|