MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL APPLIER; MITEK OMNISPAN MENISCAL APPLIER

Catalog Number 228143

Device Problems Unknown (for use when the device problem is not known) (2204); Failure to Fire (2610)

Patient Problems Unknown (for use when the patient's condition is not known) (2202); No Information (3190)

Event Date 07/06/2015

Event Type  Injury  

Event Description

Wanting suturing with omnispan, the gun did not work and when forcing the gray trigger, "stole" and it could not be put the suture again.There were no patient consequences, and the procedure was not extended greater than 30 minutes.The following additional information was received from our affiliate via email on (b)(6) 2015; the surgeon removed part of the meniscus due to this failure.See associated medwatch # 1221934-2015-00895.

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 it if 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.Visual observation of the applier revealed the main pusher rod (grey trigger) was slightly bent downwards and stuck outside of the end of the barrel of the gun which is typical of aggressively removing the needle following use.When tested for its functionality, the red trigger functioned properly when pulled on without a needle attached to the device.The needle attachment key feature, which attaches the needle to the applier, had no anomalies.Other than this possibility, a root cause for the user to have experienced this failure cannot be determined.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes (b)(4) 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

Wanting suturing with omnispan, the gun did not work and when forcing the gray trigger, "stole" and it could not be put the suture again.There were no patient consequences, and the procedure was not extended greater than 30 minutes.The following additional information was received from our affiliate via email on 7-21-15; the surgeon removed part of the meniscus due to this failure.See associated medwatch # 1221934-2015-00895.

• Brand Name: OMNISPAN MENISCAL APPLIER
• Type of Device: MITEK OMNISPAN MENISCAL 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 Key: 4963418
• MDR Text Key: 6189264
• Report Number: 1221934-2015-00896
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2015
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention