Please note correction to section h6 (device code).This device is concomitant and did not contribute to the reported elongated hole.No allegation against the nail in original condition was confirmed and no adverse consequences reported.As per reported event the drilling was performed by free-hand technique and the operative technique clearly instructs the steps to be performed for freehand technique.Furthermore, the labelling t2 tibial nailing system instructs as following: ¿4.2 intra-operative.¿ avoid surface damage of implants.¿ discard all damaged or mishandled implants.¿.The reported event of drill contact to the metal implant during free-hand drilling could be confirmed since details available revealed evidence of damaged nail hole.Due to non-available device in question and counterpart nail used [as per details given ¿nail remained implanted¿] a physical inspection was impossible and further technical statement could not be given.An elongated nail hole could only be confirmed based on the image provided.However, the labelling clearly instructs not to use damaged or mishandled implants and to discard them.The individual steps for free-hand drilling are described in the corresponding operative technique in detail, which clearly points out: ¿the critical step with any freehand locking technique is to visualize a perfectly round locking hole with the c-arm.¿.Finally, based on details available an exact root cause could not be determined but since nothing was reported during pre-functional check, which is required per ifu, it could not be excluded that the event is rather related to a sub-optimal intraoperative procedure during free-hand drilling.¿.Complementary information about this event can be found under the main investigation for the drill.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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