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

Model Number 9735278

Device Problem Material Integrity Problem (2978)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

The unique identifier was not known at the time of the event.The manufacturer representative went to the site to test the navigation system.The screwdriver was to be replaced.The manufacture date was not known at the time of the event.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 functional endoscopic sinus surgery (fess).It was reported that the tip of the screwdriver broken during an iliac screw placement.The broken part was removed from the screw and was confirmed to be removed by the health care professional.The probable cause of the reported issue was that the fact that it was a cannulated screwdriver, the walls might have been too thin for the torque applied with a screw.The next step was for the screwdriver to be replaced.There was less than an hour delay in the case.No impact on patient outcome.

• Brand Name: SCREWDRIVER KIT
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11602223
• MDR Text Key: 243377694
• Report Number: 1723170-2021-00862
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 170722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• 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: 69 YR
• Patient Weight: 82