MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214140
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device was received and evaluated.Visual observation revealed excessive tissue debris at the distal end of the applier at the grooved exit point of the needle when deployed.To test its functionality, an eiii needle was loaded into the device and was tested on a sample rubber strip.When the trigger was actuated to deploy the needle, there was slight resistance and the deployment was rough.To restore it to the original position, the needle trigger has to be pushed back manually.The device did not function smoothly as reported, confirming this complaint.This device is required to be thoroughly cleaned and properly lubricated/ milked to avoid friction during deployment.Improper maintenance would lead to tissue or bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.This failure can be attributed to field wear due to improper maintenance.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 or Problem Description
It was reported by the sales rep that the customer's expressew iii without hook didn't work on a rotator cuff surgical procedure due to the needle not passing correctly through the tissue and sticking while trying to pass through the rotator cuff.The sales rep was present for the case and reported that there were no patient consequences or delays.The device is being returned for evaluation.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: EXPRESSEW III W/O HOOK
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8267838
• Report Number: 1221934-2018-52955
• Device Sequence Number: 11313522
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 214140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1