MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PERCUTANEOUS REFERENCE CROSS PIN FRAME; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9732353

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.The suspect reference frame was returned to the manufacturer for analysis.It was reported that the push button on the base of the unit was disengaged.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Event Description

A medtronic representative reported that, while outside of a procedure, the per reference frame pin was handle/stem was reported to have been damaged.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Lot number and device manufacturer date provided.

• Brand Name: PERCUTANEOUS REFERENCE CROSS PIN FRAME
• 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: amos jarrette ; 826 coal creek circle; attn:product quality experienc; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6768288
• MDR Text Key: 81920105
• Report Number: 1723170-2017-03186
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• 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
• Report Date: 10/06/2017

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: 9732353
• Device Lot Number: 7040614523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2007
• 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