MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9731780

Device Problems Bent (1059); Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2009

Event Type  malfunction  

Manufacturer Narrative

Site declined to provide patient demographic information.05/04/2009 medtronic spinal & biologics division analysis of suspect part: the instrument was returned for evaluation.Visual examination found that the reversing axis is broken in the middle.The superior jaw presents a small lateral bending, as well as the tip of the binding screw.Breakage appears to be due to an over-torque of the binding screw.The bending of the different components may have occurred during tightening or may have been present before use.No corrective action is required at this time - the fault is attributed to improper use.A review of the complaint history found no additional information to add to this investigation.No parts have been received by manufacturer for analysis - discarded.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, the handling unit of the tightening screw on their open spine clamp was broken during use.No further details regarding the damage, or when in the procedure it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: OPEN SPINE CLAMP, TITANIUM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5498591
• MDR Text Key: 40259688
• Report Number: 1723170-2016-00234
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9731780
• Device Lot Number: 080222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2009
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1