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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM
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ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W0AN00002
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 3003853072-2021-00102.
 
Event Description
It was reported that threads of three blockers were damaged during surgery.They were removed and replaced with other blockers to complete the procedure without patient impacts.This is report three of three for this event.
 
Manufacturer Narrative
Device evaluation: visual inspection revealed both returned plugs have thread damage.One of the plugs also has drive mechanism damage/deformation.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during plug insertion.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
 
Event Description
It was reported that threads of three blockers were damaged during surgery.They were removed and replaced with other blockers to complete the procedure without patient impacts.This is report three of three for this event.
 
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Brand Name
BLOCKER
Type of Device
INSTINCT 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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key12391423
MDR Text Key268909814
Report Number3003853072-2021-00104
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W0AN00002
Device Lot NumberV18130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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