MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, DOUBLE SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734723
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect clamp was returned to the manufacturer for evaluation.Visual inspection found that the retainer ring was removed from the adjustment screw.This results in the clamp being able to tighten but not open.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.
Event or Problem Description
A site representative reported that, while in a spinal fusion, the washer for the spine clamp broke off the clamp.The reported issue occurred pre-operative and was discovered when the instrument tray was opened.No additional information was provided.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

• Brand Name: CLAMP, DOUBLE SPINOUS PROCESS TALL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6517663
• Report Number: 1723170-2017-01775
• Device Sequence Number: 736546
• Product Code: OLO
• UDI-Device Identifier: 00643169936331
• UDI-Public: 00643169936331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

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: 9734723
• Device Lot Number: 150126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1