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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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 Key12524468
MDR Text Key273098011
Report Number1030489-2021-01209
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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