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 Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.The suspect handle has been received by the manufacturer for evaluation.Confirmed reported issue as the end cap has been broken off the handle.Otherwise, the instrument retention and ratchet mechanisms are fully functional 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.

Event Description

A medtronic representative reported that during spinal fusion procedure, while the ratcheting handle was being used the bottom plate on the pummel fell off.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No impact on patient outcome.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7142002
• MDR Text Key: 95651510
• Report Number: 1723170-2017-05209
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/22/2017

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: 9734410
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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