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

Catalog Number 214140

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's expressew iii without hook jaw was loose. The sales rep stated that when the jaw bit down on the tissue, it would not hold. The sales rep stated that the surgeon was not grabbing too much tissue. The case was completed with another like-device with no patient harm or delay. The sales rep was not present and could not provide any additional information. The availability of the device is unknown.

• Brand Name: EXPRESSEW III W/O HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• 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 ; 6103142063
• MDR Report Key: 8307552
• MDR Text Key: 135940695
• Report Number: 1221934-2019-56332
• Device Sequence Number: 1
• Product Code: LHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 214140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown