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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 Difficult to Remove (1528); Unknown (for use when the device problem is not known) (2204)
Patient Problems Injury (2348); No Information (3190)
Event Date 05/26/2015
Event Type  Injury  
Event Description
During the suture of an internal meniscus, the needle stayed jammed in the joint after withdrawal of the gun.Need of a direct surgical approach in order to retrieve it.No consequences to the patient.The following additional information was received via email from our affiliate on (b)(6) 2015; direct surgical approach means «opened surgery » or invasive approach.See associated medwatch # 1221934-2015-00853.
 
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.In process.
 
Event Description
During the suture of an internal meniscus, the needle stayed jammed in the joint after withdrawal of the gun.Need of a direct surgical approach in order to retrieve it.No consequences to the patient.The following additional information was received via email from our affiliate on 7-7-15; direct surgical approach means " opened surgery" or invasive approach.See associated medwatch # (b)(4).
 
Manufacturer Narrative
The complaint devices were received and evaluated.Visual observation of the applier revealed the main pusher rod (gray trigger) was slightly bent upwards which is typical of aggressively removing the needle following use.Moreover, there is a lot of tissue debris and stains on the main rod.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.The needle attachment key feature, which attaches the needle to the applier, had no anomalies.The complaint needle was loaded properly and was secure.The silicon tube on the returned needle was bound up and damaged.As it was reported that both implants were deployed properly, it is possible that the damage to the silicon tube occurred when the needle was removed from the joint space.Moreover, the damage to the silicon tube would not have caused the needle to fall.One possible hypothesis is that the latching mechanism of the applier was opened before the applier was removed from the joint space, causing the needle to detach.Other than this possibility, a root cause for the user to have experienced this failure cannot be determined.A batch record review has been conducted and the 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 two other dissimilar complaints for this lot of devices that were released to distribution.Based on the overall complaint rate and customer impact, at this point in time, no further action is warranted.However, 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
During the suture of an internal meniscus, the needle stayed jammed in the joint after withdrawal of the gun.Need of a direct surgical approach in order to retrieve it.No consequences to the patient.The following additional information was received via email from our affiliate on (b)(6) 2015; direct surgical approach means «opened surgery » or invasive approach.See associated medwatch # 1221934-2015-00853.
 
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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
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4896815
MDR Text Key16071898
Report Number1221934-2015-00852
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
Report Date 06/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
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 Number3748758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/08/2015
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer06/08/2015
Date Manufacturer Received06/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2014
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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