MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MAS CAN DRIVER 5.5/6.0; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9735278
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.Device lot number and serial number, unavailable at time of filing.Device not returned to manufacturer for evaluation.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported a solera driver tip broke off during surgery.The tip of driver was left in the screw head.The procedure was completed with the use of navigation.There was no reported impact to the patient.No additional information was provided.
Additional Manufacturer Narrative
Additional information: further review of the reported issue found there was no bio-compatibility risk with the fragments left in the patient.

• Brand Name: MAS CAN DRIVER 5.5/6.0
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7574390
• Report Number: 1723170-2018-02549
• Device Sequence Number: 2044354
• Product Code: OLO
• UDI-Device Identifier: 00643169340657
• UDI-Public: 00643169340657
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/12/2018

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: Physician
• Device Catalogue Number: 9735278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/12/2018
• 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