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

Model Number 9735024

Device Problems Imprecision (1307); Material Integrity Problem (2978)

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

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Patient weight not available from the site.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 in a procedure.It was reported that the health care professional (hcp) was performing a hardware removal of l2-3 and reinstrumentation of l2-4.  they removed a 7.5 x 55mm screw from the left l3 pedicle and opted to replace it with an 8.5x55mm screw using solera 5.5/6.0.  as they were advancing the 8.5x55mm screw, they noted that the purchase of the screw was significant.  the screw was advanced and they moved onto the right side using a 7.5x55mm screw.  then they went back to the left l3 pedicle screw to advance it a few more millimeters.  when they did this, the tip of the navigation screw driver broke off in the t25 portion of the screw head.  they were able to retrieve the broken piece after several attempts, and both pieces were accounted for.No further information was received.Additional information was received stating that the health care professional was extending the construct to include an adjacent level. they felt as though the 7.5x55mm screw that was removed did not have adequate purchase and therefore opted for a larger diameter screw.This was not a revision procedure the screw was not misplaced. the type of procedure that was being performed was removal of hardware l2-3, l2-4 posterior spine fusion with plif at l3-4. there was a delay of approximately 10-15 minutes.Navigation was not aborted and there were no adverse events that occurred with the patient.The site used a new screw driver once the one they were using broke.The potential cause of the reported issue was that the navigated drivers should be reverse threaded in the tulip.  the manufacturer representative believes that the soft tissue contact with the driver shaft loosened the interface between the threaded portion and the screw. this places increased load on the t25 driver tip and ultimately so much load that it failed. .

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11700891
• MDR Text Key: 247020000
• Report Number: 1723170-2021-01068
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 200601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2020
• 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 Outcome(s): Other
• Patient Age: 65 YR