MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP 9734724 DOUBLE PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734724
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7034525
• Report Number: 1723170-2017-04665
• Device Sequence Number: 1332015
• Product Code: OLO
• UDI-Device Identifier: 00643169936461
• UDI-Public: 00643169936461
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Catalogue Number: 9734724
• Device Lot Number: 150815
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/15/2017; 01/11/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/11/2017; 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 84