MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9735024
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that intra-operatively, the tip of the screw driver broke off into the screw head.The surgeon was not able to remove the broken piece and decided to leave it in as the rod and bolt retained it.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.It was suspected that applying too much force/torque was the probable cause of the broken tip.
Additional Manufacturer Narrative
Additional information: the driver was returned to the manufacturer for analysis.Analysis found that the tip of the driver had been broken off.The hardware investigation found that the reported event was related to a hardware issue.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.

• Brand Name: DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8713759
• Report Number: 1723170-2019-03612
• Device Sequence Number: 11331478
• Product Code: OLO
• UDI-Device Identifier: 00643169340657
• UDI-Public: 00643169340657
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: 160715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 101