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

Catalog Number 228143

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2016

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.Udi: (b)(4).The lot expiration date is currently unavailable.Awaiting device return.

Event Description

At the moment to make the second suture point, the suture point was locked.The coating of the needle come out of the needle and was within the joint, surgery lasted for removing the coating.The anchor is removed and other anchor is placed.Additional information was received via email from the affiliate on (b)(4) 2016 it was the silicon tubing that fell into the joint.The first anchor was removed.This did not cause damage to the meniscus by removing the anchor.Yes, the surgeon used the same hole to complete the procedure.

Manufacturer Narrative

Additional narrative: the complaint device was received and evaluated.Visual observation of the device reveals the pusher rod connected to the grey trigger was slightly bent up on the end.Other than this observation there were no anomalies seen on the device.This is possibly due to forced loading/unloading of the needle.When the trigger was operated, there was slight resistance noted but fully functional.It cannot be determined at what point the pusher rod was bent.This could have possibly caused the misfiring.Also another possible cause of this defect could be if the silicon tube is pushed into the meniscus upon removal it could possibly have slid off of the needle.A definitive root cause cannot be determined at this point from the details provided.A batch record review has been conducted and 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 mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution on june 30, 2014 with an expiration date of march 31, 2017.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.(b)(4).

• 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: 5530831
• MDR Text Key: 41311278
• Report Number: 1221934-2016-10111
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3784106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2016
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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 Age: 59 YR