MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY NAVIGATED OCT SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV3606030
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
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 healthcare provider via manufacturer representative regarding a patient with c1, c2 fracture for fusion.It was reported that the spinous process clamp was not stable when clamped on the c2 spinous process due to the drill bit the tap not advancing in the bone.The physician had to push hard to get them to engage and therefore the anatomy shifted.The amount of force applied to get the tap to engage was what led to the misalignment and loss of fidelity.A c2 screw was placed directly in the vertebral artery and the patient was taken to ir after surgery to confirm no further action was needed.There were no patient symptoms or complications reported as a result of this event.Additional information received from the manufacturer representative that the instruments were dull and hard to advance.Physician felt the nav 2.4 drill bits (brand new) and our taps were dull.There was a 1 hour delay in procedure due to re-spinning and trying to seat the rod with the misplaced screw at c2 additional information received from the manufacturer representative that the event is an out of box failure as per physician.The general observation of the physician on the system was that bits taps are dull and lead to pushing harder on them to engage.The extra force applied to get them to engage is what caused the fracture to shift.There would not be a return as the hospital has the items in their possession.Additional information received from the manufacturer representative that when there is an adverse event in the or, the hospital collects the items in question.Rep will send the product for evaluation if the hospital releases the instruments in future.

• Brand Name: INFINITY NAVIGATED OCT SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11066048
• Report Number: 1030489-2020-01850
• Device Sequence Number: 2875787
• Product Code: OLO
• UDI-Device Identifier: 00643169725423
• UDI-Public: 00643169725423
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173338
• 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): 12/23/2020

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 Model Number: NAV3606030
• Device Catalogue Number: NAV3606030
• Device Lot Number: CA17M014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/23/2020
• 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: 74 YR