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 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that, while in a procedure, the spine clamp was found to be damaged.The representative reported that the patient was affected, however no additional details were provided.No additional information was provided.

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).Additional information: patient demographics, device lot number and manufacture date provided.A medtronic representative reported that the issue occurred in a single space, posterior non-segmented insert arthrodesis lumbar spinal fusion.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.

Manufacturer Narrative

Correction: there was a reported delay to the procedure of less than 1 hour due to this issue.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7034525
• MDR Text Key: 92866185
• Report Number: 1723170-2017-04665
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169936461
• UDI-Public: 00643169936461
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734724
• Device Lot Number: 150815
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 11/15/2017; 01/11/2018
• Supplement Dates FDA Received: 12/11/2017; 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2015
• 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
• Patient Age: 57 YR
• Patient Weight: 84