MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INTERBODY INSERTER CAPSTONE & CLYDESDALE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734456

Device Problems Bent (1059); Material Deformation (2976); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement capstone and clydesdale inserter shipped to site (b)(6) 2016.No parts have been received by manufacturer for analysis.On (b)(6) 2016 a medtronic representative, following-up at the site, reported the screw will not thread into the cage.Stripped thread.No further issues have been reported.Part not received by manufacturer.

Event Description

A site representative reported a faulty transforaminal lumbar interbody fusion (tlif)/direct lateral interbody fusion (dlif) inserter.The inserter part of this instrument does not screw in the cage.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

A medtronic representative went to the site to replace the instrument and test the equipment.The replacement instruments passed the system checkout.The system was then found to be fully functional.

Manufacturer Narrative

The hardware investigation of the returned inserter found that the reported event was related to a mechanical issue.Visual inspection found evidence of physical damage in that the threads of the tip of the insert were slightly damaged and the knob of the end of the insert was broken off.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: INTERBODY INSERTER CAPSTONE & CLYDESDALE
• Type of Device: ORTHOPEDIC 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5694503
• MDR Text Key: 46387021
• Report Number: 1723170-2016-01006
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734456
• Device Lot Number: 120613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/05/2016; 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• 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