MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TACTILE AWL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734435

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(6) patient privacy regulations.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that while in a spinal fusion the tactile awl became bent.The surgeon had the tactile awl placed in the pedicle, they tried to change directions and then after removing discovered the damage, there was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

The suspect awl was returned to the manufacturer for evaluation.Testing found that the tip of the instrument was bent.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: TACTILE AWL
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6198119
• MDR Text Key: 63088050
• Report Number: 1723170-2016-05899
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994759610
• UDI-Public: 00613994759610
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124004
• 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: 06/05/2017

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: 9734435
• Device Lot Number: 150915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1