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

Catalog Number 9733037

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

Patient gender and weight were not made available from the site, per coordinator (b)(4).Device lot number is not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement axiem spine reference clamo shipped to site 01/20/2016.No parts have been received by manufacturer for analysis.On 02/04/2016 a medtronic representative, following-up at the site, reported the damaged clamp is no long in use and has been returned to manufacturer.

Event Description

A medtronic representative reported that, while in a spine procedure, the site's spine reference clamp in the vertex max set was damaged.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

Lot number and device manufacture date provided.Additional information: a medtronic representative reported that another clamp was used to finish the surgery.Device evaluation: the hardware investigation found that the reported event was related to a hardware issue.One of four "claws" at the end of the clamp was broken off.Clamp also showed signs of physical damage in what appeared to be tool marks on outer surface of claws.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: SPINE REFERENCE CLAMP
• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5417693
• MDR Text Key: 37733538
• Report Number: 1723170-2016-00172
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733037
• Device Lot Number: 131011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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: 83 YR