MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228141

Device Problem Firing Problem (4011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable; therefore, the exp date is unavailable.The complaint device was received and evaluated.The needle was stuck onto the end of omnispan gun.The silicon sleeve was not attached on the needle.The needle was removed from the end of the applier and the applier was tested and functioned as intended.This failure could have been caused if the user over-penetrated the needle during usage.When the needle is over-penetrated, result in a lot of needle length behind the meniscus, the silicone and implants can get ¿bound up¿, the implants may be shifted out of place, and silicone can develop prominent ridges that can catch on tissue and fat pad ¿ all of which could lead to difficulty in deployment.It cannot be determined at what point in time this failure occurred.This complaint can be confirmed.A batch review was not conducted for the needle as the batch number is unknown.However, depuy synthes mitek will continue to track any related complaints for this needle within this device family as a means of monitoring the extent with which this complaint is observed in the field.A review into the depuy synthes mitek complaints system for the omnispan gun revealed no other complaints of any kind for this lot of devices that were released to distribution.Therefore, at this point in time, based on the overall complaint rate for this failure mode, no further action is warranted.At this point in time, no further action is warranted.However, depuy synthes 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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

This is report 2 of 2 for the same event.It was reported by the sales rep that during an anterior cruciate ligament repair surgical procedure, it was observed that the customer's omnispan meniscal applier would not fire.The sales rep reported that the triggers would not squeeze or move.The surgeon completed the procedure with another like device with no patient consequences or delays.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: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 8253589
• MDR Text Key: 133533113
• Report Number: 1221934-2018-51161
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: 10886705010035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2016

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 Catalogue Number: 228141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• 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