On the literature article named "comparing two intramedullary devices for treating trochanteric fractures: a prospective study", the authors of the study reported that, when treating patients with the imhs system for a peri trochanteric fracture, one distal locking screw missed the nail.It is unknown if / how the issue was resolved.
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The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the data presented in the aged article reported when treating patients with the imhs system for a peri trochanteric fracture, one distal locking screw missed the nail.It is unknown if / how the issue was resolved.Per subsequent email, under the master (b)(4), no further information will be provided.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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