MAUDE Adverse Event Report: BOSS INSTRUMENTS LTD; CUTTER, WIRE

Catalog Number 79-0050

Device Problems Break (1069); Device Fell (4014)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 07/16/2020

Event Type  Injury  

Event Description

An adult female was undergoing a t3-ilium posterior spinal fusion.The bolt cutter broke, and a small piece of it fell into the left chest though the spine incision.Ct surgery was consulted intra-operatively to assist with removal.This necessitated over sewing and stapling of a hole in the lung parenchyma, partial lung resection, and left chest tube placement was done and the foreign body was found.There was bleeding in this area that required 4l intravenous fluids, 4 units of packed red blood cells, 1-unit fresh frozen plasma, 1-unit platelets.Patient needed a chest tube and required an icu admission.

• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): BOSS INSTRUMENTS LTD; 104 sommerfield drive; gordonsville VA 22942
• MDR Report Key: 10343568
• MDR Text Key: 201001922
• Report Number: 10343568
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 79-0050
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7300 DA