MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) RATCHETING EGG HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734410
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested for suspect ratcheting egg handle.No parts have been received by manufacturer for analysis.On 10/13/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Damaged ratcheting egg handle requested to be replaced.Part not received by manufacturer.
Event or Problem Description
A site physician reported that, while in a spine procedure, their egg handle impactor was broken.The damage occurred during a navigation system and imaging system demo procedure.The surgeon hit the impactor 6 - 8 times with a hammer 280 gr.Before it broke.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

• Brand Name: RATCHETING EGG HANDLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6092433
• Report Number: 1723170-2016-02884
• Device Sequence Number: 1694414
• Product Code: OLO
• UDI-Device Identifier: 00613994724007
• UDI-Public: 00613994724007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2016

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: Physician
• Device Catalogue Number: 9734410
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 51