MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150 MM DISPOSABLE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9733236

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Spinal Column Injury (2081); No Consequences Or Impact To Patient (2199); Iatrogenic Source (2498)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested but has not been provided.The device was returned to the manufacturer for analysis.Perc pin fit into the perc cross pin reference frame with no issues.Found external damage to the perc pin due to pliers being used by customer to extract pin from ilium mount which would not contribute to the cause of the failure.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized a medtronic navigation product.There is no allegation to suggest that the navigation system or instrumentation caused or contributed to the reported event.

Event Description

A medtronic representative reported that "during posterior spinal fusion, an attempt to place the percutaneous pin 150mm to the ilium and attach a cross pin frame was made.The percutaneous pin was advanced about 1 cm, but it was so hard ,and the pin could not be advanced further, nor pulled out.The percutaneous pin 150mm was pulled out forcibly using pliers, and it was replaced with a percutaneous pin 100mm and another attempt was made.Then the pin could be advanced and the cross pin frame was attached successfully.The procedure was completed using navigation.No patient impact has been reported." medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized a medtronic navigation product.There is no allegation to suggest that the navigation system or instrumentation caused or contributed to the reported event.

Manufacturer Narrative

A medtronic representative reported that a new hole and incision were not required for the second insertion of the perc pin.They changed to another pin for the second attempt.Per this new information, a revision surgery was not necessary, there was no change to the surgical approach, and there was no reported impact to the patient.If this information was available during submission of the initial mdr it would not have been considered an adverse event.The above fields were corrected to reflect that the reported incident was associated with a product problem type of mdr.Per further hardware engineering review, analysis confirmed the physical damage due to the pliers being used on the device but was unable to confirm a failure that would cause "the pin could not be advanced further, nor pulled out." a review of the instructions for use (ifu) that accompanies the device found that the ifu instructs the user to select the appropriate size percutaneous pin (use the shortest pin that reaches bone through the surrounding tissue).Based on the reported event the site staff did not select the "appropriate size" and was unsuccessful in placing the incorrect pin size.

• Brand Name: 150 MM DISPOSABLE PIN
• 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; louisville, CO 80027 ; 7208902082
• MDR Report Key: 5746743
• MDR Text Key: 48093417
• Report Number: 1723170-2016-01217
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733236
• Device Lot Number: 131009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention