MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC HANDLE 9733734 RATCHETING QC SM STRGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9733734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ratcheting handle was returned to the manufacturer for analysis.Analysis found that the part retention mechanism had a broken retainer ring.As a result, the retention cover and spring has separated from the handle.Analysis found that the reported event was related to a mechanical issue.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that when the manufacturer representative received the nac navlock tray back, the ratcheting handle was damaged.There was no patient present when this issue was identified.

• Brand Name: HANDLE 9733734 RATCHETING QC SM STRGHT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8039910
• Report Number: 1723170-2018-05512
• Device Sequence Number: 1526334
• Product Code: OLO
• UDI-Device Identifier: 00643169089600
• UDI-Public: 00643169089600
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: No Information
• Device Model Number: 9733734
• Device Catalogue Number: 9733734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1