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

Model Number	NAV2132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via field representative regarding a patient who undergone spinal therapy with an indication of stenosis.It was reported that during tlif procedure the tip of the inserter broke off while implanting the elevate cage, and upon inspection after the case, the inner locking tube was bent at the tip and there was no device breakage with inner locking tube.No fragment of the device remaining in the patient.There was surgical delay of 10 minutes.Levels implanted l4-5.No patient symptoms or complications as a result of this event.No additional surgery or treatment performed as a result of this event.Product utilized correctly according to the directions given in the ifu/labeling.No further complications were reported.
Additional Manufacturer Narrative
Product analysis after visual and optical examination, it appears that one of the prongs has been sheared off the inserter's tip.The prong was not returned.This is consistent with overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVIGATED INSTRUMENTS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11357180
• Report Number: 1030489-2021-00234
• Device Sequence Number: 3416396
• Product Code: OLO
• UDI-Device Identifier: 00643169771000
• UDI-Public: 00643169771000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163581
• 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,Followup
• Report Date (Section B): 06/08/2021

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: NAV2132
• Device Catalogue Number: NAV2132
• Device Lot Number: DN17A001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1