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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
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2020
Event Type  Malfunction  
Manufacturer Narrative

Visual inspection revealed the tip has fractured. Medical records were not provided for review. Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the instrument was being used or handled at the time of the damage. Dhr review: per 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 , a follow-up report will be sent.

 
Event Description

It was reported that a final driver was worn during surgery. However, the tip was found to have fracture off when the device was evaluated by the manufacturer. Another driver was used to complete the surgery without patient impacts.

 
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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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key11574810
MDR Text Key243557278
Report Number3003853072-2021-00022
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCH
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
Report Date 03/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number046W1AN00641
Device LOT NumberA2649802A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/02/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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