MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP 9734724 DOUBLE PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734724

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identification (udi) is unavailable.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.Part not returned.

Event Description

Medtronic received information regarding a navigation instrument being used for a sacroiliac and thoracolumbar procedure.It was reported that there was a damaged spine clamp.The screw pulled out of the mechanism and the clamp was unable to fully open.There was no impact to the patient outcome and no delay due to the reported issue.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect clamp was returned to the manufacturer for evaluation.Visual inspection found that the retainer ring was removed from the adjustment screw.This results in the clamp being able to tighten but not open.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.

• Brand Name: CLAMP 9734724 DOUBLE PROCESS SHORT
• 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: 7512180
• MDR Text Key: 108239683
• Report Number: 1723170-2018-02024
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734724
• Device Lot Number: 160223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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: 56 YR
• Patient Weight: 95