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

Catalog Number 228143

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Associated medwatch 1221934-2016-10272.

Event Description

The sales rep reported that during a meniscal repair procedure after pressing the first gray trigger the customer's meniscal deployment 12 degree gun and the customer's omnispan meniscal repair, both implants fired at the same time and the silicone sheath pulled off the needle.The sales rep reported that the surgeon completed the procedure by performing a meniscectomy and removing part of the meniscus.The sales rep reported that there was a 15 minute delay in the case.The sales rep stated that the device was loaded properly and that the doctor has plenty of experience with the devices.The sales rep stated that the needle did not penetrate the meniscus.The sales rep is not sure if the failure is due to the gun or the implants.The device will be returning for evaluation.

Manufacturer Narrative

Additional narrative: the complaint device was not returned for evaluation.A root cause cannot be determined; however, one possible root cause is the failure mode 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.Based on the information provided and the devices that were returned we cannot confirm this complaint.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our 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 one similar complaint for this lot of devices that were released to distribution.At this point in time, no corrective action is required and 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.(b)(4).Associated medwatch 1221934-2016-10272.

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: MENISCAL INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5787646
• MDR Text Key: 49362597
• Report Number: 1221934-2016-10273
• 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
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3825914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2016
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• 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