MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problem Firing Problem (4011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was received and evaluated.Visual observation of the device reveals the pusher rod was bent downward.This is possibly due to forced loading/unloading of the needle.There were a lot of tissue accumulation on the loading rod (red trigger), but no damage.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.It cannot be determined at what point the pusher rod was bent.This could have possibly caused the misfiring.A definitive root cause cannot be determined at this point from the details provided.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.Based on the overall complaint rate, at this point in time, no further action is warranted.However, 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.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.This report is being filed from the (b)(4) 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 affiliate in (b)(6) that during mensical repair surgical procedure, it was observed that when the first point of the suture was placed, the suture fired properly and when shooting with the red trigger to advance the next point, the second point of the suture did not advance.There was no delay in the procedure which was completed by the surgeon using another device.The needle was loaded in the correct orientation.The surgeon used the same location for the second implant.The red trigger of the gun did not move when depressed and the there surgery group did hear a 'click'.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: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8252293
• MDR Text Key: 133954975
• Report Number: 1221934-2018-50863
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 228143
• Device Lot Number: 3837471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Date Manufacturer Received: 10/29/2015
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1