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 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The lot number is currently unavailable; therefore, the exp date is unavailable.Investigation summary: the complaint device, one needle, was received and evaluated.The applier was received with one needle stuck in the applier.The silicon tube on the needle was bounded up and pushed towards the proximal end of the needle.The needle had to be forced out of the gun.The reported 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.The location of the silicon tube and how it was bound up, confirms this root cause, which is considered a user technique error.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 3 of 3 for the same event.It was reported by the affiliate in (b)(6) that after the beginning of the meniscus repair surgery, it was observed that the applicator did not fire correctly.According to the reporter, the needle has been changed and a new needle has been used.It was further reported that the same problem appeared with the second needle.A new applicator was then used and no further problems.Therefore the problem seems to be within the applicator.All were used within one surgery.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: 8249037
• MDR Text Key: 133967888
• Report Number: 1221934-2019-56003
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: 10886705010035
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150209
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• 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: 10/18/2016
• Date Manufacturer Received: 05/12/2016
• 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