MAUDE Adverse Event Report: DEPUY MITEK MITEK OMNISPAN MENISCAL APPLIER

Catalog Number 228143

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 10/30/2014

Event Type  Injury  

Event Description

The sales rep reported that during an acl repair the two of his omnispan meniscal appliers and two of his omnisplan meniscal repair systems, 12 degree needles would not deploy the 2nd implant.The sales rep reported that while deploying the 2nd backstop the spring went under the 2nd backstop and jammed the device.This was repeated with the 2nd applier and implant.The surgeon completed the procedure by removed the meniscus and moving on with no patient consequences.There was a 30 minute delay in the procedure.See associated medwatch 1221934-2014-00523, 1221934-2014-00524, 1221934-2014-00525.

Manufacturer Narrative

The complaint device was not returned to mitek and therefore a physical evaluation cannot be performed and a specific failure of the device cannot be determined.A root cause for the device to have malfunctioned cannot be discerned.No further technique or device details were provided to determine the root cause of the failure.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 mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.Based on the complaint history for this type of failure and patient harm, at this point in time, no further action is warranted.However, depuy 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.

• Brand Name: MITEK OMNISPAN MENISCAL APPLIER
• Type of Device: 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: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4273264
• MDR Text Key: 19087967
• Report Number: 1221934-2014-00526
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3783994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2014
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• 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): Other