MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SOLERA TAPS AND DRIVERS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV2016K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using an awl for a sacroiliac and thoracolumbar (lower/mid spine) surgery.It was reported that the sharp tip broke off (approx 1-2mm).The product came in contact with the patient.There were no patient symptoms or complications as a result of the event.Level implanted was l4.The product will be replaced by a medtronic product in the future.No further complications were reported/ anticipated.

• Brand Name: SOLERA TAPS AND DRIVERS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10366099
• Report Number: 1030489-2020-01032
• Device Sequence Number: 19564864
• Product Code: OLO
• UDI-Device Identifier: 00643169541054
• UDI-Public: 00643169541054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140454
• 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): 08/05/2020

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: NAV2016K
• Device Catalogue Number: NAV2016K
• Device Lot Number: CA16D059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1