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

MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING T-HANDLE INSTINCT JAVA SYSTEM

  • 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
 

ZIMMER SPINE TORQUE LIMITING T-HANDLE INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00650
Device Problem Calibration Problem (2890)
Patient Problem No Code Available (3191)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
Udi#: (b)(4). Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference reports 3003853072-2020-00099 to 3003853072-2020-00102.
 
Event Description
It was reported that during surgery, the surgeon was reviewing the c-arm image and decided he needed to adjust the angle of the screw. When he attempted to remove the screw, the tips of two final drivers broke, the broken tips were retrieved the blocker stripped in the tulip head and the screw could not be pulled out. It was reported that the torsion force of t-handle is too large, which leads to the fracture of screwdriver. There was an approximate 20 minute delay and competitor product was used to complete the case. There were no reported patient impacts. This is report 1 of 4 for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTORQUE LIMITING T-HANDLE
Type of DeviceINSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer (Section G)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer Contact
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key10503271
MDR Text Key206000113
Report Number3003853072-2020-00099
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number046W1AN00650
Device Lot NumberA200673405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-