• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK EXPRESSEW III SUTURE NEEDLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK EXPRESSEW III SUTURE NEEDLE Back to Search Results
Catalog Number 214141
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2018
Event Type  malfunction  
Event Description
Tip of suture passer broke off when the surgeon was passing the suture through the tendon of the left shoulder, c-arm brought in and tip of suture passer was located and retrieved and no injury noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXPRESSEW III SUTURE NEEDLE
Type of DeviceEXPRESSEW III SUTURE NEEDLE
Manufacturer (Section D)
DEPUY MITEK
raynham MA 02767
MDR Report Key7533851
MDR Text Key109103423
Report NumberMW5077363
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number214141
Device Lot Number45230
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-