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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. NAVIGATION CANNULATED T27 BONE SCREW DRIVER VITAL NAVIGATION SYSTEM

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ZIMMER BIOMET SPINE INC. NAVIGATION CANNULATED T27 BONE SCREW DRIVER VITAL NAVIGATION SYSTEM Back to Search Results
Catalog Number 854M0021
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: visual inspection revealed that the tip of the driver is twisted. Potential cause root cause was unable to be determined. This event could possibly be attributed to wear through use over time or multiple sterilization cycles. It could also be attributed to off-axis forces applied during use. 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
The tip of a screw inserter was found to be twisted during a routine inspection. The specific surgical or patient information is unknown.
 
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Brand NameNAVIGATION CANNULATED T27 BONE SCREW DRIVER
Type of DeviceVITAL NAVIGATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key13690653
MDR Text Key286768375
Report Number3012447612-2022-00057
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number854M0021
Device Lot Number312476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2020
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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