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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK OMNISPAN MENISCAL APPLIER; MENISCAL IMPLANT APPLIER
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DEPUY MITEK MITEK OMNISPAN MENISCAL APPLIER; MENISCAL IMPLANT APPLIER Back to Search Results
Catalog Number 228143
Device Problems Positioning Failure (1158); Unknown (for use when the device problem is not known) (2204)
Patient Problems Surgical procedure aborted/stopped (2563); No Information (3190)
Event Date 06/03/2015
Event Type  Injury  
Event Description
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.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
MITEK OMNISPAN MENISCAL APPLIER
Type of Device
MENISCAL IMPLANT APPLIER
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4898769
MDR Text Key6021568
Report Number1221934-2015-00855
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 06/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Catalogue Number228143
Device Lot Number3754618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/10/2015
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer06/10/2015
Date Manufacturer Received06/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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