MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RATCHETING HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date, unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation and spinal instruments being used intra-operatively of a spinal l4/5 stenosis procedure.It was reported that the legacy ratchet and provisional break off.The ratchet handle broke.They did not break inside the patient anatomy.There was no impact on the patient income.Additional information was received stating that all three instruments were all broken.The provisional would no longer retain the break off screws.The ratchet handles were no longer working.The caps on top fell off.

• Brand Name: RATCHETING HANDLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10950980
• Report Number: 1723170-2020-03177
• Device Sequence Number: 11560635
• Product Code: OLO
• UDI-Device Identifier: 00643169089600
• UDI-Public: 00643169089600
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 9733734
• Device Catalogue Number: 9733734
• Device Lot Number: 66300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1