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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; SIMILAR TO INSTINCT JAVA SYSTEM

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ZIMMER SPINE BLOCKER; SIMILAR TO INSTINCT JAVA SYSTEM Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2020
Event Type  malfunction  
Manufacturer Narrative
This device is not cleared in the us, but is similar to k111301.Device evaluation: visual investigation reveals that the inner hexes on four of the blockers were stripped.Functional investigation using mating parts showed that the blockers with damaged threads were non-functional because they could not fully engage the blocker holder.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during tightening.Dhr review and related actions: per the dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.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 3003853072-2021-00005 thru 3003853072-2021-00008.
 
Event Description
It was reported that the hex on five blockers were stripped during installation within surgery.However, device evaluation by the manufacturer found that the threads on four of the blockers were stripped.The blockers were removed and replaced during the surgery without patient impact.This is report three of four for this event.
 
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Brand Name
BLOCKER
Type of Device
SIMILAR TO 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 Key11346102
MDR Text Key232586786
Report Number3003853072-2021-00007
Device Sequence Number1
Product Code NKB
UDI-Device Identifier03700456000155
UDI-Public(01)03700456000155(10)E89815(11)151105
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberSN2023-0-00002
Device Lot NumberE89815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight77
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