MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LUMBAR PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734402

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

During part analysis there was a confirmed physical damage failure with the probe.This issue was documented in a medtronic navigation hardware tracking database.

Event Description

A medtronic representative reported that the lumbar probe was bent.There was no patient impact reported and the delay in surgery was less than an hour.Surgery proceeded as planned.

Manufacturer Narrative

The visual inspection of the suspect probe found that the tip of the probe was bent and twisted.

• Brand Name: LUMBAR PROBE TIP
• 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
• MDR Report Key: 6404182
• MDR Text Key: 69948335
• Report Number: 1723170-2017-01165
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994724021
• UDI-Public: 00613994724021
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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: Health Professional
• Device Catalogue Number: 9734402
• Device Lot Number: 160606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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
• Patient Age: 76 YR
• Patient Weight: 129