MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERC PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9733235

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

H3, h6) the instrument has not returned to the manufacturer for analysis.Codes b17, c20, and d15 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.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.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that there was a 100 millimeter (mm) percutaneous (perc) pin that did not fit in the tap cap.The post was too large.The issue was discovered outside of the operating room, there was no patient involvement.

• Brand Name: PERC PIN
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18941272
• MDR Text Key: 339237728
• Report Number: 1723170-2024-00854
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994247872
• UDI-Public: 00613994247872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Model Number: 9733235
• Device Catalogue Number: 9733235
• Device Lot Number: 2023060369
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1