MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TRACKER ARRAY CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110008

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

It was reported that the tracker clamp came apart during cleaning and processing and sales rep was not able to put it back together.No during surgery.

• Brand Name: NAVIO TRACKER ARRAY CLAMP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth; minnesota,
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth; mn
• Manufacturer Contact: richard con ; 2905 northwest blvd ste 40; suit 100; pittsburg,
• MDR Report Key: 9994378
• MDR Text Key: 189491608
• Report Number: 3010266064-2020-19091
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2020

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: PFSR110008
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 04/24/2020
• 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