MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST 960-717 ADJ DRILL STOP, 3.2MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-717
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not made available from the site.Device lot number is unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.On (b)(6) 2017 a medtronic representative, following-up at the site, reported that he inspected all three sets that included inst adj drill stop 3.2mm.All instruments were tested and found to be functioning properly, no issues were identified.It was deemed likely the drill stop used in this event was not properly locked in place, allowing the drill to go deeper than desired.The site sterile processing department (spd) head and technicians were all re-trained on the use of the 3.2mm inst adj drill stops and demonstrated they understood locking/unlocking of the device correctly.No parts will be returned to the manufacturer for analysis as there are no malfunctions.This event was determined to be use error.The site confirmed the patient in this event suffered no injury and was recovering "just fine", as expected.There are no further issues.
Event or Problem Description
A medtronic representative received a report on (b)(6) 2017, alleging that on (b)(6) 2017, while in a spine procedure, the site's universal drill guide (udg) drill stop was not functioning properly, and the drill went deeper than expected.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
Type of event, adverse event updated as the reported issue was found to be an adverse event due to the drill going deeper into patient than intended.

• Brand Name: INST 960-717 ADJ DRILL STOP, 3.2MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6491850
• Report Number: 1723170-2017-01034
• Device Sequence Number: 816000
• Product Code: HAW
• UDI-Device Identifier: 00673978090498
• UDI-Public: 00673978090498
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 960-717
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention