Catalog Number 228143 |
Device Problem
Unknown (for use when the device problem is not known) (2204)
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Patient Problem
Surgical procedure aborted/stopped (2563)
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Event Date 06/03/2015 |
Event Type
Injury
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Event Description
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The handle of the gun was blocked and didn't work; so, the anchor 228141 has not been implanted.Use of a second device but the same problem occurred.So the meniscus was not sutured.Need to operate on the patient again but no date for the moment.See associated medwatch # 1221934-2015-00855.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
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Event Description
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The handle of the gun was blocked and didn't work; so, the anchor 228141 has not been implanted.Use of a second device but the same problem occurred.So the meniscus was not sutured.Need to operate on the patient again but no date for the moment.See associated medwatch # 1221934-2015-00855.
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Manufacturer Narrative
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The complaint device was received and evaluated.The device was received with a needle loaded without the implants.Visual observation reveals no anomalies on the device or the returned needle.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.A 0 degree needle was loaded onto the applier and both implants were deployed successfully.The applier works as intended and we cannot confirm the reported complaint.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.A root cause for the user to have experienced this failure cannot be determined.Depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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The handle of the gun was blocked and didn't work; so, the anchor 228141 has not been implanted.Use of a second device but the same problem occurred.So the meniscus was not sutured.Need to operate on the patient again but no date for the moment.See associated medwatch # 1221934-2015-00855.
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Search Alerts/Recalls
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