MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III NEEDLE PK5; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number 214141

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during a rotation cuff procedure, doctor was using an expressew iii needle, and it presented failures, remaining stuck in the forceps at the time of use.The complaint device was received and inspected.Visual observation under magnification revealed no anomalies in the structure of the device.In addition, the plastic flag is missing from the needle.Besides, the expressew used in the procedure was not received in the package.The complaint cannot be confirmed.The possible root cause for the reported failure can be attributed to an improper maintenance would lead to tissue or bio-debris build up inside the expressew shaft causing wear of internal components and generate a resistance during the deployment.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required and 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.

Event Description

It was reported by the affiliate in (b)(6)that during a rotator cuff repair procedure on (b)(6) 2020, it was observed that the expressew iii needle device had an undetermined malfunction that it remained stuck in the forceps at the time of use.During in-house engineering evaluation, it was determined that the plastic flag was missing from the needle.There was no delay in the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: EXPRESSEW III NEEDLE PK5
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• 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: 10838136
• MDR Text Key: 216350350
• Report Number: 1221934-2020-03482
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020225
• UDI-Public: 10886705020225
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 214141
• Device Catalogue Number: 214141
• Device Lot Number: 51557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2019
• 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