SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 05/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Kulkarni, m.S., tummala, m., aroor, m.N., vijayan, s., & rao, s.K.(2020).Suprapatellar nailing in proximal third tibial fractures-clinicoradiological outcome.Injury, 51(8), 1879-1886.Doi: 10.1016/j.Injury.2020.05.008.
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Event Description
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It was reported that on literature review "suprapatellar nailing in proximal third tibial fractures - clinicoradiological outcome", 1 patient suffered from non-union with bone loss which required bone grafting.Eventually all achieved union.No further information is available.
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Manufacturer Narrative
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H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without 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 any additional relevant medical information be provided, this case would 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.The contribution of the device 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 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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