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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 Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Surgical procedure aborted/stopped (2563)
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 # 1221934-2015-00855.
 
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.In transit.
 
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 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.
 
Manufacturer Narrative
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.
 
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 # 1221934-2015-00855.
 
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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 Key4898823
MDR Text Key16851387
Report Number1221934-2015-00856
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
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 Date10/31/2016
Device Catalogue Number228143
Device Lot Number3748751
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 Age17 MO
Event Location Hospital
Date Report to Manufacturer06/10/2015
Date Manufacturer Received06/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2014
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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