MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9731780

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

Site representative, operating room (o.R.) nurse, declined to provide patient information.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement small straight ratcheting handle shipped to site.No parts have been received by manufacturer for analysis.

Event Description

A site representative operating room (or) nurse, reported that, while in a spine procedure, the end cap, hammerable, fell off of the site's small straight ratcheting handle while in use.No further details regarding the damage, or how 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 patient present when this issue was identified.

Manufacturer Narrative

Although a specific cause of the reported incident was unconfirmed as the part was not returned to the manufacturer, further engineering review of the complaint history at this account found that the reported issue was similar to an existing hardware investigation documented in a medtronic navigation hardware anomaly tracking database.

Manufacturer Narrative

Correction: product, unique device identification (udi) and associated fields updated to proper value.

• Brand Name: OPEN SPINE CLAMP, TITANIUM
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5546192
• MDR Text Key: 41821317
• Report Number: 1723170-2016-00466
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9731780
• Device Lot Number: 70611
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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