MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734680

Device Problem Material Integrity Problem (2978)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding navigation instruments being used intra-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the navlock thoracic probe broke off in the patient at the 20mm mark.They swapped to the lumbar probe and the lumbar probe tip twisted.These instruments are from the new tray.The issue extended the surgical time by less than 1 hour.There was no impact on the patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information: the surgeon left a portion of the instrument inside the patient.

• Brand Name: NAV THORACIC PROBE TIP
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9311513
• MDR Text Key: 178334712
• Report Number: 1723170-2019-05576
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 190417
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 12/12/2019
• 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 Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 82