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U.S. Department of Health and Human Services

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

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ZIMMER SPINE FINAL SCREWDRIVER SHAFT INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W1AN00640
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2018
Event Type  Malfunction  
Manufacturer Narrative

Udi number: ni. (b)(6). 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.

 
Event Description

It was reported that the tip of a final screwdriver broke off during tightening within surgery. An alternative driver was used to complete the procedure without reported patient impacts.

 
Manufacturer Narrative

Udi number: (b)(4). The driver was not returned so an evaluation was unable to be performed. Therefore, there are no results available and no conclusions can be drawn. A review of the manufacturing records did not identify any issues that would have contributed to this event.

 
Event Description

It was reported that the tip of a final screwdriver broke off during tightening within surgery. An alternative driver was used to complete the procedure without reported patient impacts.

 
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Brand NameFINAL SCREWDRIVER SHAFT
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
dorothee fleuri
23 parvis des chartrons
cite mondiale
bordeaux, cedex 
33521905
MDR Report Key8202792
MDR Text Key132383442
Report Number3003853072-2018-00121
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeRS
PMA/PMN NumberK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number046W1AN00640
Device LOT NumberA2491402A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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