SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION 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
Implant Pain (4561)
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Event Date 02/14/2020 |
Event Type
Injury
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Event Description
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It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2015, in which a hfn 10mm x 16cm left nail was implanted along with four screws placed across the proximal tibial (x2), distal transverse (x1) and distal posteroanterior (x1) region to treat a post-traumatic ankle & subtalar arthritis, the patient experienced fibular hypertrophy and pain localized in the area of the tibial and transverse screws.An additional surgery was performed on (b)(6) 2020 to treat this adverse event.The two proximal tibial screws, along with the distal transverse screw, were explanted, but there is no confirmation on whether additional screws were implanted in exchange.Despite this incident, a complete fusion in the treated hindfoot joints was confirmed by x-ray assessment 3 months postoperatively, although it is unknown if the reported time frame is related to the primary surgery or to the additional intervention performed.The reported incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
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Manufacturer Narrative
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(b)(4).
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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 contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the post-market clinical follow up activity (pmcf) was anonymous.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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 but not limited to procedural/user error, surgical complication or patient medical history.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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