SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES,ARTHROSCOPIC
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Catalog Number 72203793 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2018 |
Event Type
malfunction
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Event Description
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It was reported that the distal tip of the needle, approx.1-2mm broke off and one of the two tips that did break couldn't not be located and removed from the patient.
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Manufacturer Narrative
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One truepass suture shuttle needle was returned for evaluation.Visual examination of the needle confirmed the reported complaint.The needle tip has broken off at the suture slot.The broken tip was not returned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force on the needle during use, inadequate visibility when using the device.Needle tip becoming lodged in bone.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This is an acknowledged failure mode that has been evaluated and is being monitored through our post market surveillance.A review of the device history records associated with this manufactured lot confirmed that no abnormalities were reported with this product during manufacture.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) reportedly the surgeon unsuccessfully attempted to retrieve the truepass needle tip, creating a >30-60 minute procedural delay.The device has not been returned for analysis.It was reported that the breakage of the needle tip and the extended surgery time did not result in any patient harm.The patient did not require any additional medical intervention and no additional harm is anticipated.No further clinical assessment is warranted in this case.
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Manufacturer Narrative
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Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) reportedly the surgeon unsuccessfully attempted to retrieve the truepass needle tip, creating a >30-60 minute procedural delay.The device has not been returned for analysis.It was reported that the breakage of the needle tip and the extended surgery time did not result in any patient harm.The patient did not require any additional medical intervention and no additional harm is anticipated.No further clinical assessment is warranted in this case.
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