MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) APT EGG QUICK CONNECT HANDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-339

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for analysis.

Event Description

A site representative reported that while in a spinal fusion procedure, the metal piece on the back ratcheting handle broke while being hammered.The surgeon was able to continue the surgery with another handle and completed the procedure with the use of the navigation system.There was a reported delay of less than 1 hour due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

Medtronic investigation of returned suspect device finds that the end cap has been broken off.The handle is otherwise functional.The reported event was confirmed to be caused by physical damage.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.

Manufacturer Narrative

Further engineering analysis was completed on the returned suspect device and found the lot number indicates part is almost 3.5 years old.This is an uncommon failure mode on this part due to the relatively large size of the impact cap, covering the majority of the hind end of the handle.

• Brand Name: APT EGG QUICK CONNECT HANDLE
• 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 ; 7208902338
• MDR Report Key: 5321222
• MDR Text Key: 34198974
• Report Number: 1723170-2015-01610
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954276
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-339
• Device Lot Number: 120929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2012
• 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
• Patient Age: 40 YR
• Patient Weight: 75