MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL APPLIER ORTHOPAEDIC CERCLAGE APPLIER

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.

• Brand Name: OMNISPAN MENISCAL APPLIER
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7707516
• MDR Text Key: 114802213
• Report Number: 1221934-2018-52356
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 228143
• Device Lot Number: 3754612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial