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

Catalog Number 9734456

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that during spinal fusion procedure, the tip of the inserter bent upon insertion.The procedure was completed with the use of navigation.There was no delay to procedure.No impact on patient outcome.

Manufacturer Narrative

Correction: instrument unique device identification (udi) updated to proper value.

Manufacturer Narrative

Correction: initial reporter: (b)(6).

Manufacturer Narrative

The capstone and clydesdale inserter was returned to the manufacturer for analysis.Analysis found that the tip of the inserter was broken off on one side.The cause of the breakage could not be determined.Analysis found that the reported event was related to a physical damage issue.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.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7331072
• MDR Text Key: 102139056
• Report Number: 1723170-2018-01104
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2018

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
• Device Operator: Physician
• Device Catalogue Number: 9734456
• Device Lot Number: 120613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/21/2018; 09/11/2018; 09/14/2018
• Supplement Dates FDA Received: 04/11/2018; 09/11/2018; 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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