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

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.

• 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 Key: 12524454
• MDR Text Key: 273103354
• Report Number: 1030489-2021-01208
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: 6550006
• Device Catalogue Number: 6550006
• Device Lot Number: EM19G003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/24/2021
• 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 Number: 1