The reported event that a self-drilling half pin apex ø 3mm, 110 x 25mm broke during surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The surgeon used the self-drilling half pin apex ø 3mm, 110 x 25mm in a navigation procedure.This is off-label use.Indeed, the operative technique of this system states clearly that ¿apex pins are not intended for navigation procedure purposes¿.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Labeling extracts: the operative technique (apex-st-1 en apex pins op tech) was reviewed: ''pin insertion guidelines [.] caution: apex pins are not intended for navigation procedure purposes.'' [original statement(s)].The instruction for use ((b)(4) non active implant ifu (b)(4)) was reviewed: ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.[.] for your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).'' [original statement(s)].
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It was reported that during a navigated primary tka on patient's right knee, 2 apex pins broke off at time of insertion.The surgeon took x-rays and determined that it would cause the patient more harm to remove the broken pieces than leaving them in would be.Rep reported that there was no surgical delay and that the procedure was completed successfully.Rep also reported that no further medical reports, patient data, or x-rays are available due to surgeon policy.
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