SMITH & NEPHEW, INC. TRIGEN INTERTAN INTERTROCHANTERIC ANTEGRADE NAIL; NAIL, FIXATION, BONE
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Catalog Number UNKNOWN |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Laceration(s) (1946)
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Event Date 03/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Zhao, f., guo, l., wang, x., & zhang, y.(2021).Benefit of lag screw placement by a single-or two-screw nailing system in elderly patients with ao/ota 31-a2 trochanteric fractures.Journal of international medical research, 49(3), 03000605211003766.Doi: 10.1177/03000605211003766.
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Event Description
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It was reported that on literature review "benefit of lag screw placement by a single- or two-screw nailing system in elderly patients with ao/ota 31-a2 trochanteric fractures", 4 patients experienced cut out after an interlocking intramedullary nail procedure in the femur using an intertan nail fixation implant.It is unknown how this event was treated.No further information is available.
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Manufacturer Narrative
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H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to bone degeneration, lack of ingrowth, surgical technique, patient anatomy, abnormal loading and/or traumatic injury.The contribution of the devices to the reported event could not be corroborated.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 devices 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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