STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 18063100 |
Device Problem
Break (1069)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 11/23/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Once the investigation has been completed any additional information will be reported in a supplemental report.
|
|
Event Description
|
Customer reported that whilst using t2 recon nail, the registrar and scrub tested to see if they lined up with the jig.They took an x-ray and everything seemed ok, therefore proceeded to drill through the canal.When looking at the lateral view x-ray, they realized the screw missed the nail.They removed the 2 screws and adjusted the nail to try again, but the k-wire hit the nail and small piece of wire broke off.This was left in the patient and they decided not to continue this method.They successfully completed the surgery using antegrade technique by putting the screw through the lesser trochanter.There was a 45 minute delay.Delay of 45 minutes, unintended metal (k-wire) left in patient.
|
|
Manufacturer Narrative
|
The event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard.Product surveillance will continue to monitor complaints of this type for adverse trends.
|
|
Event Description
|
Customer reported that whilst using t2 recon nail, the registrar and scrub tested to see if they lined up with the jig.They took an x-ray and everything seemed ok, therefore proceeded to drill through the canal.When looking at the lateral view x-ray, they realized the screw missed the nail.They removed the 2 screws and adjusted the nail to try again, but the k-wire hit the nail and small piece of wire broke off.This was left in the patient and they decided not to continue this method.They successfully completed the surgery using antegrade technique by putting the screw through the lesser trochanter.There was a 45 minute delay.Delay of 45 minutes, unintended metal (k-wire) left in patient.
|
|
Search Alerts/Recalls
|
|
|