MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; INSTRUMENT, STEREOTAXIC

Model Number	960-717
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device/components were received at the time of filing.Manufacture date was not available at the time of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a universal drill guide drill stop being used with a navigation system.It was reported that intra/peri-operatively during the verify instruments task of a cervical spine procedure, the drill stop was incredibly hard to move up and down to lock and unlock and when the drill bit was in the drill stop it was incredibly loose and kept falling.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
The drill stop was returned to the manufacturer for analysis.Analysis via functional testing and visual/physical examination confirmed the reported issue.There was a mechanical failure; specifically the ring on the drill stop was very tight when pushed toward the open end of the drill stop.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information.The site used the same drill stop through the case, the scrub tech just had a hard time locking it but eventually got it each time.

• Brand Name: N/A
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8137512
• Report Number: 1723170-2018-06091
• Device Sequence Number: 1579473
• Product Code: HAW
• UDI-Device Identifier: 00763000055394
• UDI-Public: 00763000055394
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Model Number: 960-717
• Device Catalogue Number: 960-717
• Device Lot Number: 181011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 01/31/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/09/2019; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 68