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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SOLERA VOYAGER 5.5; SCREWDRIVER

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MEDTRONIC SOFAMOR DANEK USA, INC SOLERA VOYAGER 5.5; SCREWDRIVER Back to Search Results
Model Number 6550006
Device Problems Degraded (1153); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
Product analysis of part # 6550006 ; lot # em19g003 analysis summary: visual and optical inspection confirmed the hex of the driver has been damaged and one of the tabs has broken.The hex edges have been rounded off.Without the tab the screw cannot be loaded or released properly.This type of failure is consistent with bent stress overload during angulation of the driver.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from health care provider via manufacturer representative regarding an event happened during intra-op for a patient under going a procedure of t10-pelvis instrumented fusion.The pre-operative diagnosis was mentioned as adult scoliosis of the lumbar spine.The set screw drivers, they were not retaining set screws.The tips of the drivers seem to be worn down a little bit so they had to replace with additional drivers.There were delays in the case due to these issues.The surgeon had to spend time locating the broken item within the wound, as well as had to spend additional time on finding drivers.There were no symptoms to patient or physician were reported.No additional treatment or surgery performed.All the reported products came in contact with patient.No further complications reported.
 
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Brand Name
SOLERA VOYAGER 5.5
Type of Device
SCREWDRIVER
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12524454
MDR Text Key273103354
Report Number1030489-2021-01208
Device Sequence Number1
Product Code HXX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/24/2021
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 Number6550006
Device Catalogue Number6550006
Device Lot NumberEM19G003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/16/2021
Initial Date FDA Received09/24/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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