The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned nail has explantation marks on the proximal surface.There are a few drill marks and bearing points at the distal drill hole of the received nail.There are also no prominent marks of set screw on the superior flute of the received lag screw which indicate that the set screw was not properly seated and locked.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.The instructions for use instructs user that: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.The risk of post-operative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.For this reason those patients must have additional post-operative follow-up.¿ based on investigation, the root cause was primarily attributed to a user related issue along with secondary patient factor issues (low activity level, former smoker, heavy alcohol intake).The migration of the lag screw happened due to inadequate insertion of the set screw inside the nail, leading to inadequate fixation of the lag screw with the set screw and setting it free.If any further information is provided, the complaint report will be updated.
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