MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) THORACIC CLAMP, RADIOLUCENT; INSTRUMENT, STEREOTAXIC

Model Number 9733148

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Missing udi number and lot number.No instrument has been returned to the manufacture for analysis.Missing manufacture date.Part not returned.

Event Description

Medtronic received information regarding a navigation device.It was reported that the clamp 9734716 spinous process short was difficult to put on and take it off.The site had replaced this part a couple of times already.There was no patient present when this issue was observed.

Manufacturer Narrative

The thoracic spine clamp was received by the manufacturer for analysis.Analysis found that the returned clamp was in like new condition with no apparent physical damage.There was no fault found with the returned thoracic spine clamp.Device manufacturing date updated to proper value.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device.It was reported that the thoracic clamp was difficult to put on and take off.The site had replaced this part a couple of times already.There was no patient present when this issue was observed.

• Brand Name: THORACIC CLAMP, RADIOLUCENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7817851
• MDR Text Key: 118275243
• Report Number: 1723170-2018-04241
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733148
• Device Catalogue Number: 9733148
• Device Lot Number: 180315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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