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Correction: refer to d4 catalog number, gtin.The reported event could be confirmed, since the device was returned, and x-rays provided.The device was returned and shows that indeed, the distal part of the screw was torn for the rest of the screw.The root cause of this event was probably due to the contact of the screw with hard bone, and the application of too much force on this size of screw.Indeed, the reported implant is of size 4.0 mm and was used on a tibia and fibula bone.The size of screw recommended for these bones on the operative technique is a 5.0mm screw.Furthermore, since the operative report and some x-rays were provided, the opinion of a medical expert was requested.His statement is as follows: "[.] from the report attached it is quite unclear what actually happened and how.[the operative report reads] "doctor placed 2 threaded guidewires through the near and far cortex of the fibula and in the near cortex of the tibia for a total of 3 cortices.The doctor measured for the screw which was a 40 and drilled with the cannulated 2.7 drill bit.As he entered near tibial cortex, he felt a slight click and we got an x-ray of an unfamiliar object.As we further investigated with fluoroscopic x-ray we predicted that the screw was tearing itself apart." the report shows a k-wire was drilled through the fibula into the tibia.After this it says that a 2.7 cannulated drill was used (2.7mm).However, if a drill was used before actual screw insertion (they are self tapping and self drilling), how can it be that a foreign object was touched while using the drill.The sentence at the end of the paragraph speaks of the screw tearing apart.From the x-ray it is unclear whether the third cortex was drilled at all, it is very dense along the k-wire.So my guess is the third cortex was not drilled (entirely).There is a clear note on the page with the indications and contraindications: note: contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.[.]" based on this statement, the root cause for the device breakage is attributed to the lack of predrilling the cortices of the tibia bone before inserting the screw.Indeed, although the asnis screws are self drilling and self tapping, in the presence of hard bone (the patient was 37), the operative technique warns the user about the possibility of damage of the implant.Moreover, the operative technique states that : "indications statement: the asnis iii cannulated screw system is intended for fracture fixation of small and long bones and of the pelvis.The system is not intended for spinal use." based on this statement, the medical expert says: "[.] it is debatable whether syndesmosis stabilization is included in the above statement.The stabilization of the syndesmosis is actually a treatment for the tibiofibular joint due to soft tissue damage of the ligaments and not a fracture treatment.[.]" therefore, the use of asnis cannulated screws to treat syndesmosis stabilization could be considered off-label use of the device.A review of the device history for the reported lot 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 complaint report will be updated.
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