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

Catalog Number 9730027

Device Problems Unstable (1667); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. Device lot number not available. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. (b)(4) 2016 a medtronic representative, following-up at the site, reported speaking with the doctor. The surgeon reported that the open spine clamp did not broke rapidly, in one moment, it got worse and worse over time until the moment when he decided it should be replaced. The surgeon stated surgery was performed normally to the last day. (b)(4) 2016 further details from the medtronic representative confirm the hexagon joint between the driver and the clamp became more round. The surgeon stated that the place where he inserts the driver to tighten the screw became more loose and he would have to put more effort into tightening the screws. Return requested for open spine clamp; no parts have been received by manufacturer for analysis.

Event Description

A site physician reported an open spine clamp that had a broken thread. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.

Manufacturer Narrative

Correction to suspect medical device. Further review of the returned components found that the driver was the cause of the reported event. Brand name, catalog # and lot #, and concomitant medical product and therapy dates were updated to reflect the findings below. Medtronic investigation of returned suspect driver finds that the returned driver is very worn. The tip of the driver is rounded out making it difficult to engage the head of the clamp. The reported event was confirmed to be caused by a mechanical failure mode. 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. Medtronic investigation of returned suspect clamp finds that the returned clamp was found to be in good condition. There is no damage to the threads of the adjustment screw. The clamp is fully functional.

• Brand Name: OPEN SPINE CLAMP DRIVER
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5461193
• MDR Text Key: 39086315
• Report Number: 1723170-2016-00254
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 9730027
• Device Lot Number: 091010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse