The reported incident that the one-step insertion wrench omega failed to connect with the rest of the one-step assembly system (s-31 / no fitting) could not be confirmed, since the device was returned for evaluation and it was verified that it is fully functional and manufactured according to the specifications.The ¿one-step insertion wrench omega¿ has a slightly scratched surface.The cannulation looks clean, while the lower part of the wrench, where the pegs are located, looks in a very good condition without any scratches or deformations.The one-step assembly, with the use of all the received devices, was performed, and it was identified that the lag screw cannot be assembled with the rest of the system, because its deformed surface does not allow the bolt to be inserted within the cannulation of the screw.However, the ¿one-step insertion wrench omega¿ can be perfectly assembled with the rest of the system without causing any malfunctions.The one-step assembly, with the use of all the received devices but in combination with a new lag screw (with the same catalog no), was performed, and it was identified that the system can be assembled without any malfunctions and can perform according to the specifications.Most likely during usage of the whole one-step assembly system, the lag screw was not properly assembled with the rest of the devices and this caused the disconnection during the insertion process.This matches with the reported event that ¿the t-handle was being turned but the lag screw was no longer turning, and the x-ray imaging showed small fragments of broken metal and a disconnection of the lag screw with the one-step-insertion device¿.Normally the notches of the lag screw are assembled with the pegs of the wrench, and the bolt is used to keep them together.If the lag screw was not properly assembled or tightly screwed with these devices, then potential play could be created, which could definitely compromise the contact surface and lead to a breakage/deformation of the screw.On top of that, due to the transmitted torque from the handle to the rest of the devices, in combination with a wrong assembly, a plastic deformation could definitely be generated.This is evident, since the deformed surface of the screw has signs of rotation that could easily be created if during rotation of the lag screw, the near-by device was not correctly attached and destroyed the surface of the screw as it came in contact with it.For that reason, please pay attention to what is clearly written in the op.Tech.: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.Implants which consist of several components must only be used in the prescribed combination." if the devices were not used in the right way and order, a disassembly could have been created leading to a deformed surface as the one reported.Furthermore, please be aware of what is indicated in the ifu: ¿inspection is recommended prior to surgery to determine if implants have been damaged during storage.Instruments should be examined for wear or damage prior to surgery.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other, while during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ it was also reported that the customer removed the lag screw with the ¿use of the lag screw inserter, which is comprised of the lag screw adapter assembly, lag screw inserter and lag screw inserter sleeve.¿ however, in the op.Tech it is clearly written that if the need for hardware removal arises, ¿the lag screw is extracted after removal of the hip plate through use of the large elastosil t-handle connected to the lag screw inserter and the connecting bolt.¿ using a wrong system to remove the lag screw can definitely lead to a deformed surface as the one received.Therefore, once again, please pay attention to the op.Tech.: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.Implants which consist of several components must only be used in the prescribed combination." a deviation from the instructions for use, can lead to physical changes (deformations, scratches, damages) of the material which may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Since the screw was extracted in a wrong way it is evident that its surface was completely deformed, and as a result a proper inspection cannot be performed.Last but not least, for cannulated devices, the users should always ¿ensure that bone debris does not accumulate in the cannulation of the instrument.¿ therefore appropriate cleaning and inspection should be performed in order to avoid any of the mentioned situations.According to the cleaning and sterilization guide, ¿the instruments which are supplied in a non-sterile condition must be subjected to an appropriate cleaning and sterilization process before use.Pay particular attention to cannulations and blind holes.Generally un-magnified visual inspection under good light conditions is sufficient.Particular attention should be paid to recessed features (holes, cannulations).Based on the above mentioned observations, the root cause was attributed to a user related issue.Most likely a not proper assembly of the devices, and a mishandling during removal, led to a deformation of the screws` surface.A review of the device history for the reported ¿one-step insertion wrench omega¿ did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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