MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734715

Device Problems Mechanical Problem (1384); Device Inoperable (1663); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Medtronic investigation of returned suspect spinous process tall clamp finds that the retainer ring has been pulled from the tip of the adjustment screw and is missing.As such, the adjustment screw is able to set the clamp but not able to release it.This condition is caused by turning the adjustment screw further than the design will allow while opening the clamp.Physical damage - pieces missing.- hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.

Event Description

A medtronic representative received a report from a site that their spinous process tall clamp is not opening up.It appears the ring to allow proper function is missing.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6532997
• MDR Text Key: 74039323
• Report Number: 1723170-2017-01794
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734715
• Device Lot Number: 151130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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