MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, INC. NAVIO; SOFT TISSUE PROTECTOR

Model Number PFSR101092

Device Problems Bent (1059); Overheating of Device (1437); Difficult to Remove (1528); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 12/29/2016

Event Type  malfunction  

Event Description

Doctor was inserting pins (blue belt) into the drill guide and the top of the pin twisted and bent inside the drill guide.After multiple attempts to remove the pin failed.The pin was sawed off so it could be unscrewed.A new set was opened.New pins and a new drill guide was used.Additional information: the tissue protector was placed on the knee and the bone screw goes through the tissue protector.When drilling into the bone, the screw and protector heated up and caused the two parts to get fused together.The physician had to cut the bone screw off the patient and the two parts were stuck together.This has happened before and they are working on a new design.They did send us the same part number to be put back in the set.She took the part with her and was told to bring it back to the hospital.

• Brand Name: NAVIO
• Type of Device: SOFT TISSUE PROTECTOR
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, INC.; 2905 northwest blvd.; ste 40; plymouth MN 55441
• MDR Report Key: 6310379
• MDR Text Key: 66807327
• Report Number: 6310379
• Device Sequence Number: 0
• Product Code: OLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017,01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PFSR101092
• Device Catalogue Number: PFSR101092
• Other Device ID Number: THE PART # 101111 BONE SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE PART # 101092 TISSUE PROTECTORTHE PART # 101
• Patient Age: 67 YR
• Patient Weight: 161