Catalog Number 228143 |
Device Problems
Positioning Failure (1158); Unknown (for use when the device problem is not known) (2204)
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Patient Problems
Surgical procedure aborted/stopped (2563); No Information (3190)
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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 # 1221934-2015-00856.
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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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Manufacturer Narrative
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The complaint device was received and evaluated.The returned applier had a lot of tissue debris on and around the main pusher rod and the key feature parts.Visual observation of the applier reveals that the main pusher rod (gray trigger) was observed to be slightly bent.The applier was rough to operate because of the tissue accumulation between the two rod and the bent of the main rod.This damage can cause deployment issue, confirming the complaint.This bent in pusher rod is typical of aggressively removing the needle following use.A batch record review has been conducted to determine if there were any internal processing issues that would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed with no incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.Based on the overall complaint rates for this type of failure across all product families, at this point in time, no corrective action is required and no further action is warranted.However, 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 # 1221934-2015-00856.
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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 (b)(4) 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 # 1221934-2015-00856.
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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 (b)(4) 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 # 1221934-2015-00856.
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Search Alerts/Recalls
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