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

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis on the returned probe has the tip broken off.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used intra//peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the tip of the probe broken off inside the pedicle (40mm).The manufacturing representative reports that the surgeon was malleting the probe and the tip broke off.The instrument broke during the placement of 3 out of the 4 screws.2 screws were placed already on the left side, so the surgeon decided to do a unilateral fusion.The surgeon was unable to remove the piece of the probe and was left in the right l4 pedicle.There was a less than 1-hour delay to the procedure and no impact on patient outcome.

• Brand Name: NAVLOCK PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10538177
• Report Number: 1723170-2020-02457
• Device Sequence Number: 1192543
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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
• Operator of Device: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 171004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 80