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

Catalog Number	9731780
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Two lot numbers were provided for the spine clamp 110317, 160406.Manufacture date of lot 160406 is 04/06/16.Currently, clarification on which lot number is the suspect spine clamp and which was a separate proactive replacement is unavailable.On 6/26/2017 replacement parts were shipped to site.No parts have been received by manufacturer for evaluation.
Event or Problem Description
A site representative reported that during a spinal fusion procedure, the spine clamp screw head was worn.The surgery was completed with the use of another clamp.There was a delay of less than 1 hour.No impact on patient outcome.
Additional Manufacturer Narrative
Correction: legal statement inadvertently left off of follow up number 1.
Additional Manufacturer Narrative
Correction: part number and udi were inadvertently provided incorrectly in the initial mdr.Correct values are now provided in the appropriate fields.
Additional Manufacturer Narrative
Device evaluation: the suspect clamps were returned to the manufacturer and the issue confirmed.During visual inspection many nicks and cuts were observed on the clamps.One clamp was a nick in the threads of one of the adjustment screws which cause difficulty setting the clamp.The other returned clamp was fully functional.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.

• Brand Name: OPEN SPINE CLAMP, TITANIUM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6711370
• Report Number: 1723170-2017-02908
• Device Sequence Number: 2013670
• Product Code: HAW
• UDI-Device Identifier: 00643169308879
• UDI-Public: 00643169308879
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2018

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: 9731780
• Device Lot Number: 110317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 08/11/2017; 02/28/2018
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/11/2017; 08/11/2017; 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1