MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734300

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Suspect tap was not replaced and the site will not return the device to manufacturer for analysis.On 09/09/2016 a medtronic representative, following-up at the site, reported the site was unable to pass a guide wire through the tap.The site scrub tech dropped the tap on the floor which rendered it "out of use".Another scrub tech, took the tap and used an unnamed solution and a drill to remove the substance clogging the tap.Old tissue and bone was found in tap.The site expects the tap sat in sterile processing department (spd) without immediate cleaning, the previous day, after having been used in a procedure.Spd was also supposed to used a wire to clean the inside of tap during cleaning process and that was reportedly not done.The procedure was delayed 15-20 minutes, as the surgeon chose not to navigate the cannulated tap.There were no reported injuries in attempting to clean the tap.The damaged tap was removed from circulation.- no parts were replaced.- no parts have been received by manufacturer for analysis.- no further issues have been reported.This device is included in the medical device field correction notification, "potential for user injury ¿ medtronic navigated cannulated taps" (may 2015).The revised instructions for use (ifu) were also provided with the notification.

Event Description

A medtronic representative reported that, while in a spine procedure, the site's cannulated tap was found to have bone lodged within the cannula.The tap was deemed unusable in it's current condition.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue, using a second tap, and completed the procedure with the use of the navigation.There were no further issues.Delay in therapy was 15 - 20 minutes.There was no impact on patient outcome.

Manufacturer Narrative

Investigation of returned suspect tap finds that the tap is clogged with foreign tissue.The tip of the instrument is also blunted causing a fluting of the tip.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: 5.5MM TAP (CANNULATED)
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5982135
• MDR Text Key: 55788596
• Report Number: 1723170-2016-02366
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734300
• Device Lot Number: 120805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1847-2015
• Patient Sequence Number: 1