STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS 7X220 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 18301722S |
Device Problem
Fracture (1260)
|
Patient Problems
Non-union Bone Fracture (2369); Implant Pain (4561)
|
Event Date 09/30/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Upon completion of investigation, additional information will be provided in a supplemental report.
|
|
Event Description
|
As reported: "it was found that the product was broken when it was removed (humerus, right side).It was considered that it may have been broken because the nonunion state continued for a long time.There were some marks on the broken part that looked like they had been drilled, so the strength may have decreased.Additional information: the patient had pain since last year and had been treated with ultrasound, but couldn't get bone union and so it was removed.Pain, non-union, revision.
|
|
Manufacturer Narrative
|
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received nail was completely broken in the web at the uppermost a/p hole in the distal part of the nail.The entry point of the hole in the proximal segment shows severe material erosion due to a deviated drill and marks the origin point of the fracture (lateral web), also indicated by slight chip formation.Fracture propagated towards posterior from this region with an incipient crack.The fracture pattern shows lines of rest in the beginning and later followed by shiny surface (plastic deformation).This is indicative of the fact that the breakage happened in a fatigue manner, gradually, crack by crack due to cyclic loading.Consequently, the other web (medial web) broke much faster after the web on the lateral side broke.Formation of shiny surface was caused due to gradual rubbing of the separated parts before the nail finally broke.The distal segment of the nail also exhibits similar features but was much greater deformed during explantation.The most distal hole shows slightly significant bearing mark but nothing unusual.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the evaluation of the returned device, the root cause of the issue is user related.To answer to the surgeon¿s question, the breakage of nail was induced by mis-drilling during surgery which initiated an incipient crack, which gradually propagated due to cyclic loading and hence the nail broke in a fatigue manner.Although, bearing mark of the screw is present in one of the distal holes, but the nail broke first before it got overloaded due to the said non-union.If any additional information is provided, the investigation will be reassessed.
|
|
Event Description
|
As reported: "it was found that the product was broken when it was removed (humerus, right side).It was considered that it may have been broken because the nonunion state continued for a long time.There were some marks on the broken part that looked like they had been drilled, so the strength may have decreased.Additional information: the patient had pain since last year and had been treated with ultrasound, but couldn't get bone union and so it was removed.Pain, non-union, revision.
|
|
Search Alerts/Recalls
|
|
|