The reported event that long nail kit r1.5, ti, right gamma3® ø10x360mm x 125° was alleged of issue k-538 (bone fracture) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.Event description states, ¿patient had right gamma nail put in 11/11 at another hospital for a left femur fracture and subsequently broke the distal end of femur.¿ as right gamma nail is used for left femur fracture, this indicates that a wrong nail geometry was chosen.Also, patient is a female of age 91 years, most probably with poor bone quality (osteoporotic), it resulted in a bone fracture.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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