MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATED CD HORIZON SOLERA PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733235
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6) the 9733235 perc pin instrument was returned to the manufacturer for evaluation.As reported, the returned perc pin had a tight fit into several mating parts on the test bench.The cross pin measures 1.84mm and should not be wider than 1.55mm per spec.Codes b01, c07, and d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system used for a sacroiliac and thoracolumbar procedure.It was reported that there was an issue regarding a perc pin during surgery, as the instrument was defective.When attempting to insert the perc pin into the reference frame, the manufacturer representative stated that the side adapter was too large to fit.As a result, a different perc pin was brought in and was inserted without issue.There was less than an hour delay to the procedure and no impact to patient outcome.It was confirmed how the instrument got damaged.The perc pin was not damaged during the case, and it appeared the pin was manufactured incorrectly as the side adapter was too large to fit over the slots of the cross pin tap cap as well as the percutaneous reference cross pin frame.The ¿defect¿ was noticed by the physician when he attempted to place the pin on the cap before it w as inserted into the patient at the very beginning of the transforaminal lumbar interbody fusion (tlif) case.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NAVIGATED CD HORIZON SOLERA PIN
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22158805
• Report Number: 1723170-2025-02238
• Device Sequence Number: 12633436
• Product Code: OLO
• UDI-Device Identifier: 00613994247872
• UDI-Public: (01)00613994247872(17)260607(10)2023060368
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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 Expiration Date: 06/07/2026
• Device Model Number: 9733235
• Device Catalogue Number: 9733235
• Device Lot Number: 2023060368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 92 KG