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

Catalog Number	9734716
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The issue was resolved by replacing the damaged part.No part has been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that a short spine clamp was damaged.The screw was no longer tightening.It is not known when this issue was discovered.No patient was present during the time of the reported incident.No past patient impact was reported.
Additional Manufacturer Narrative
The short spine clamp was returned to the manufacturer for analysis.The adjustment screw was missing.The retainer ring has been pulled from the tip of the adjustment screw no longer limiting the travel of the screw.As a result, the screw has been backed out all the way and is now missing.The clamp is not usable as is.The hardware investigation found that the reported event was related to physical damage; pieces missing.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: CLAMP, SPINOUS PROCESS SHORT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6265169
• Report Number: 1723170-2017-00217
• Device Sequence Number: 18895954
• Product Code: OLO
• UDI-Device Identifier: 00643169540460
• UDI-Public: 00643169540460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9734716
• Device Lot Number: 150202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1