The reported incident that the tip of the ¿temp.Plate fixator pin ao fitting¿ snapped off, remaining in the patient¿s bone, when the consultant was drilling into the shaft of the bone (s-11 / breakage during surgery) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.The device was received, for evaluation, broken at the tip.The inspection revealed that apart from the broken tip, the surface of the pin does not have any significant scratches.This is compatible with what has been reported: that ¿the stated device was brand new and the first time the set has been used, was during the reported incident.¿ the threaded tip is broken, almost at the end, while the breakage surface shows signs of torsional deformation.The pin was most likely twisted under high loads and eventually broke.As per op.Tech.(axsos3_2015-7178): ¿to help prevent thermal necrosis during the drilling stage, it is recommended that the temporary plate fixator pin is inserted by hand.¿ in case excessive torque was used during the drilling process, such power, in combination with hard/dense bone, and even violent moves, could definitely deform the pin and lead to such a breakage.Particularly, if the drilling was in an inclined angle, in the hard bone, a bending moment could be generated, leading to a fracture, as the one reported.This aligns with the reported incident description, that ¿the consultant felt that the pin was bending¿.As per ifu (v15011): ¿ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument.[¿] only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.[¿] always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.¿ based on the investigation the case could be classified as user-related due to over-torque.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 investigation report will be updated.
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