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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT II INSTINCT JAVA SYSTEM

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ZIMMER SPINE FINAL SCREWDRIVER SHAFT II INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00641
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/22/2017
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that the tip of a driver fractured during surgery. The tip remains implanted in the blocker. An alternative driver was used to complete the procedure. There were no further patient impacts reported as a result of this event.
 
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Brand NameFINAL SCREWDRIVER SHAFT II
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
teresa george
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7193346
MDR Text Key97323650
Report Number3003853072-2018-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number046W1AN00641
Device Lot NumberA2447214A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/16/2018 Patient Sequence Number: 1
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