Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VILEX, INC. TITANEX DRIVER; TITANEX 2.0 DRIVER
  • 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
 

VILEX, INC. TITANEX DRIVER; TITANEX 2.0 DRIVER Back to Search Results
Model Number ZT702-06-09
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2015
Event Type  malfunction  
Manufacturer Narrative
On 06/08/2015, vilex received information regarding a driver, zt702-06-09, where the tip had chipped while loading into the handle.On 07/27/2015, vilex received driver.Vilex's quality department evaluated the driver.The only damage was to the tip of the driver.Vilex believes that the driver was either loaded into the handle backwards or was dropped.Vilex made several attempts to contact the account manager to clarify what occurred during surgery.No responses were ever received.A review of vilex's complaints revealed that no complaints have been filed against this product.Should more information become available, a follow up report will be filed.
 
Event Description
Tip of instrument (driver) broke.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TITANEX DRIVER
Type of Device
TITANEX 2.0 DRIVER
Manufacturer (Section D)
VILEX, INC.
mcminnville TN
Manufacturer Contact
111 moffitt street
mcminnville, TN 37110
9314747550
MDR Report Key5084100
MDR Text Key26191481
Report Number1051526-2015-00007
Device Sequence Number1
Product Code DWI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Report Date 09/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberZT702-06-09
Device Lot Number6627
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/29/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/18/2015
Date Device Manufactured11/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-