MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PIN PERC REFERENCE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9733235

Device Problem Fitting Problem (2183)

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

Event Date 02/21/2019

Event Type  malfunction  

Event Description

Surgeon performing spinal surgery.Stated that when he tried to put pins in array they would not fit.Opened another package and these also had issues with fit but he was able to get them in but he stated they were really tight.

• Brand Name: PIN PERC REFERENCE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 8703586
• MDR Text Key: 148158778
• Report Number: 8703586
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733235
• Device Lot Number: 2018090333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2019
• Date Report to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA