SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number UNKNOWN |
Device Problem
Fracture (1260)
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Patient Problems
Wound Dehiscence (1154); Failure of Implant (1924)
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Event Date 11/05/2013 |
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) 2012, in which a hfn 11.5mm 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 primary arthritis of ankle & subtalar joints, the patient experienced a fracture of the distal posteroanterior and transverse screws, along with a lateral superficial wound dehiscence.The patient was referred ot a wound clinic.A complete fusion of the ankle and the subtalar joint was confirmed by x-ray assesment 3 months postoperatively.This 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 traumatic injury, excessive forces applied to the implant, surgical technique, infection and/or patient condition 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.
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