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	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was completed on the system (cart 9733858 s7 assembled staff 220v) the instrument is used with.Testing found that the system performed as intended and no hardware parts were replaced.The instrument this report is filed on was not returned, so no analysis was completed.Device manufacturing date was unavailable at the time of filing.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 the silver end of the ratcheting handle where the surgeon hammers the handle had come off.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
The ratcheting handle was returned to the manufacturer for analysis.Analysis found that the returned handle had the end cap broken off.The ratchet and tool retention mechanisms were otherwise intact and functional.Analysis found that the reported event was due to physical damage.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• 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: 8182650
• Report Number: 1723170-2018-06367
• Device Sequence Number: 19371750
• Product Code: OLO
• UDI-Device Identifier: 00643169089600
• UDI-Public: 00643169089600
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Device Lot Number: 72802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1