MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) RATCHETING EGG HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734410

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device lot number unavailable.Device manufacture date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the impact plates of the egg ratcheting handle were loose.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

The ratcheting handle was returned to the manufacturer for evaluation.It was noted that the back plate was removed from the handle.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

Additional information: unique device identification (udi) and device manufacture date provided.Device lot number provided.

• Brand Name: RATCHETING EGG HANDLE
• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7614434
• MDR Text Key: 111681678
• Report Number: 1723170-2018-02869
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734410
• Device Lot Number: 104233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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