MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9735278

Device Problem Material Integrity Problem (2978)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The unique identifier was not available at the time of reporting.No parts have been received by the manufacturer for evaluation because they were discarded at the site.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that during an old screw ablation, the health care professional damaged the screw driver.There was no delay to the case.No impact on patient outcome.Additional information was received stating that the instrument was damaged inside of the patient anatomy and that all damaged pieces have been removed from the patient anatomy.The instruments were discarded at the site and will not be returning for analysis.

• Brand Name: DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11213862
• MDR Text Key: 228165384
• Report Number: 1723170-2021-00184
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/22/2021

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: 9735278
• Device Catalogue Number: 9735278
• Device Lot Number: 100108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/22/2021
• 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
• Patient Age: 28 YR
• Patient Weight: 52