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Catalog Number 228143
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/22/2014
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device was received and evaluated. Visual observation of the device revealed the main pusher rod (gray trigger) revealed that it 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, is stuck inside the shaft, and the needle couldn¿t be loaded, as a result. Upon close inspection, it was found that the main shaft is bent and causing the rods to be misaligned. This bending of the shaft is typical of an extreme load applied to the needle as would occur in a misuse condition. This failure mode, of deploying both implants at the same time, results when main pusher rod is bent upwards; the failure mode is due to the interference of the bent pusher rod with the 2nd implant during deployment. This bent rod will push the 2nd implant and 1st implant from the needle, thus deploying both implants. Therefore, the root cause most likely resulted from a use error condition that led to the bending of the main rod and shaft. A batch record review has been conducted and our results indicate that this batch of product was processed without incident that could cause this failure. Further, a review into the mitek complaints system revealed no other complaints for this lot released to distribution. Therefore, no further actions are warranted at this time. 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. Udi: (b)(4). This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event Description
This is report 1 of 2 for the same event. It was reported by the sales rep that an omnispan applier deployed both anchors at the same time when pulling the grey trigger which was meant to deploy just the first anchor during a meniscal repair. The surgeon kept both anchors inside the patient, one deploying behind the meniscus and the other not being found in the joint space. The scrub tech then went to load another needle in the device and noticed the distal tip of the applier looked visually different so they decided to use another applier to complete the procedure with no patient consequences. There was a ten minute delay. The devices are coming back for evaluation. The surgeon was formally trained by a mitek rep and there were two mitek reps present for this case. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer (Section D)
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
MDR Report Key7707516
MDR Text Key114802213
Report Number1221934-2018-52356
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2016
Device Catalogue Number228143
Device Lot Number3754612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2014
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial