MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATED CD HORIZON SOLERA SCREWDRIVERS

Model Number 9735024

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that intra-operatively, the driver broke at the time of inserting the screw.The broken tip part was collected.It was noted that only the driver used the implant driver.There was no effect on other navigation.The procedure was completed using the navigation system and back-up products.There was no reported impact to patient outcome and no reported surgical delay.

• Brand Name: NAVIGATED CD HORIZON SOLERA SCREWDRIVERS
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11446594
• MDR Text Key: 238929498
• Report Number: 1723170-2021-00629
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• 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