MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9734856
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.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 in a posterior lumbar interbody fusion (plif).It was reported that during the insertion of the screw into s1, the driver slipped and broke the tip off into the shank of the solera 4.75-7.5 mm screw.The health care professional (hcp) was able to remove the fragment of the driver from the patient causing no harm.The hcp did not tap the bone to size and may this may have contributed to the force required to insert the screw.On the other screws the hcp decided to tap on the driver.Navigation was aborted on the last screw.There was no delay to the procedure.No impact on patient outcome.No fragments were left in the patient.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8005941
• Report Number: 1723170-2018-05349
• Device Sequence Number: 1301503
• Product Code: HAW
• UDI-Device Identifier: 00643169045040
• UDI-Public: 00643169045040
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 10/25/2018

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: No Information
• Device Model Number: 9734856
• Device Catalogue Number: 9734856
• Device Lot Number: 130524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 144