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 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not made available from the site.Return requested for suspect egg quick connect handle.No parts have been received by manufacturer for analysis.Replacement egg quick connect handle delivered to site on (b)(4) 2016.No further issues have been reported.

Event Description

A site biomed representative reported that while in a spine procedure, the instrument egg quick connect handle was used with a hammer.The superior metal part fell off of the handle.No further details regarding this issue, or specifically when 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.

Manufacturer Narrative

The hardware investigation of the returned handle found that the reported event was related to a physical damage issue.As reported, the end cap was broken from the handle.The cap had many impact marks.Otherwise, the instrument retention mechanism is fully functional.The device supplier was notified of this issue.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5633825
• MDR Text Key: 44480992
• Report Number: 1723170-2016-00726
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K954276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• 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: 130422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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: 60 YR
• Patient Weight: 68