MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERC PIN ADAPTER ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734752

Device Problem Imprecision (1307)

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

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Device lot number, or serial number, unavailable. No devices were returned to the manufacturer for analysis. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that intra-operatively, the site had issues with the perc pin. While seated inside of the perc pin adapter, the site noted that there was movement which forced them to re-direct two screws after placement as the perc pin caused inaccuracy. An additional 3d confirmation spin was needed to complete the case. There was no reported impact to patient outcome. There was reported delay to the procedure of 15-20 minutes due to this issue.

• Brand Name: PERC PIN ADAPTER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8203437
• MDR Text Key: 131635032
• Report Number: 1723170-2018-06498
• Device Sequence Number: 1
• Product Code: OLO
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9734752
• Device Catalogue Number: 9734752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/28/2018 Patient Sequence Number: 1