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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 NAV DRIVER - SHAFT T20 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY SPINE INC 5.5 NAV DRIVER - SHAFT T20 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 3010-19-003
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2021, during spinal fusion surgery the surgeon was performing a posterior thoracic spine fusion with expedium poly screws using medtronic stealth navigation. While using the expedium navlock driver and inserting the screw, the tip of the driver broke off in the screw. The surgeon was able to retrieve the broken part of the driver tip from the screw and used another driver to complete the surgery. Procedure was successfully completed with five (5) minutes of surgical delay. This report is for one (1) 5. 5 nav driver - shaft t20. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name5.5 NAV DRIVER - SHAFT T20
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13053258
MDR Text Key285619638
Report Number1526439-2021-02602
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3010-19-003
Device Catalogue Number301019003
Device Lot NumberMI102001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
Treatment
SI POLYAXL SCREW 6 X 45MM
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