MAUDE Adverse Event Report: WARSAW ORTHOPEDICS INFINITY NAVIGATED OCT SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAVG3606010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
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 health care provider via a manufacturer representative regarding a patient with l4-s1 spinal stenosis due to tumor at l4-s1 for spinal surgery.The procedure performed was t2-s2 posterior spine fusion.It was reported that the surgeon used the nav infinity drill to make the starting holes to set the trajectory for the screws in the lumbar spine and pelvis.When drilling for the s2 alar iliac trajectory the tip of the drill (~30mm) broke off inside the patient¿s pelvis.The drill bit was used without the drill guide when placing the s2 screw.Surgeon then used a solera awl tip tap to change the trajectory of the pilot hole away from the fragment.A solera 5.5 screw was placed safely in the new trajectory, away from the broken fragment.Towards the completion of the case an o-arm spin confirmed the location of drill bit fragment in the patient¿s pelvis.The levels implanted was l2-pelvis.There was a fragment of the implant or instrument remaining in the patient.There were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of th is event.

• Brand Name: INFINITY NAVIGATED OCT SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10231508
• Report Number: 1030489-2020-00819
• Device Sequence Number: 3143105
• Product Code: OLO
• UDI-Device Identifier: 00643169799936
• UDI-Public: 00643169799936
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181111
• 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
• Report Date (Section B): 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2026
• Device Model Number: NAVG3606010
• Device Catalogue Number: NAVG3606010
• Device Lot Number: CA18A004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 125